Trial Outcomes & Findings for BP Management System User Acceptance Testing (NCT NCT04688450)

NCT ID: NCT04688450

Last Updated: 2025-01-27

Results Overview

Nurse-subject quantitative survey response (yes/no) about any confusion or perceived inaccuracies of the system; perceived risk of patient management error; or perceived distraction that impacted care delivery

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 20 participants
• Primary outcome timeframe: Up to 8 hours
• Results posted on: 2025-01-27

Participant Flow

Participant milestones

Measure	Intervention Group The investigational system will be evaluated for safety and user acceptance in 20 patient-subjects and associated nurse-subjects VIGORIS Blood Pressure Management Clinical Decision Support System: Software system to optimize tight blood pressure management during vasopressor infusion
Overall Study STARTED	20
Overall Study COMPLETED	18
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure	Intervention Group The investigational system will be evaluated for safety and user acceptance in 20 patient-subjects and associated nurse-subjects VIGORIS Blood Pressure Management Clinical Decision Support System: Software system to optimize tight blood pressure management during vasopressor infusion
Overall Study Unable to start software due to serial communication failure	1
Overall Study Withdrawal by Subject	1

Baseline Characteristics

BP Management System User Acceptance Testing

Baseline characteristics by cohort

Measure	Intervention Group n=20 Participants The investigational system will be evaluated for safety and user acceptance in 20 patient-subjects and associated nurse-subjects VIGORIS Blood Pressure Management Clinical Decision Support System: Software system to optimize tight blood pressure management during vasopressor infusion
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=5 Participants
Age, Categorical >=65 years	13 Participants n=5 Participants
Age, Continuous	67.5 years n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	19 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	14 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 8 hours

Nurse-subject quantitative survey response (yes/no) about any confusion or perceived inaccuracies of the system; perceived risk of patient management error; or perceived distraction that impacted care delivery

Outcome measures

Measure	Intervention Group n=20 Participants The investigational system will be evaluated for safety and user acceptance in 20 patient-subjects and associated nurse-subjects VIGORIS Blood Pressure Management Clinical Decision Support System: Software system to optimize tight blood pressure management during vasopressor infusion
Quantitative Nurse-subject Survey Response No confusion or perceived inaccuracies of the system	13 Participants
Quantitative Nurse-subject Survey Response Any confusion or perceived inaccuracies of the system but without perceived risk of management error	4 Participants
Quantitative Nurse-subject Survey Response Perceived risk of patient management error	1 Participants
Quantitative Nurse-subject Survey Response Perceived error or distraction that actually impacted care delivery during investigational protocol	0 Participants
Quantitative Nurse-subject Survey Response Did not begin protocol / no survey	2 Participants

PRIMARY outcome

Timeframe: Up to 8 hours

System malfunction (yes/no) observed in real-time by the Technical Observer

Outcome measures

Measure	Intervention Group n=20 Participants The investigational system will be evaluated for safety and user acceptance in 20 patient-subjects and associated nurse-subjects VIGORIS Blood Pressure Management Clinical Decision Support System: Software system to optimize tight blood pressure management during vasopressor infusion
Software Operation (Based on Real-time Observation) System malfunction not observed	18 Participants
Software Operation (Based on Real-time Observation) System malfunction observed	0 Participants
Software Operation (Based on Real-time Observation) Did not begin protocol / no survey	2 Participants

PRIMARY outcome

Timeframe: Up to 8 hours

Completeness (yes/no) of flowsheet (data archive of the investigational System) without any lapses in input data from the bedside monitor during connectivity; and without lapses in associated BP forecasts.

Outcome measures

Measure	Intervention Group n=20 Participants The investigational system will be evaluated for safety and user acceptance in 20 patient-subjects and associated nurse-subjects VIGORIS Blood Pressure Management Clinical Decision Support System: Software system to optimize tight blood pressure management during vasopressor infusion
Data Completeness Completeness of flowsheet observed	18 Participants
Data Completeness Incompleteness of flowsheet observed	0 Participants
Data Completeness Did not begin protocol / no survey	2 Participants

PRIMARY outcome

Timeframe: Up to 8 hours

Error-level and critical-level software errors in the runtime log (yes/no)

Outcome measures

Measure	Intervention Group n=20 Participants The investigational system will be evaluated for safety and user acceptance in 20 patient-subjects and associated nurse-subjects VIGORIS Blood Pressure Management Clinical Decision Support System: Software system to optimize tight blood pressure management during vasopressor infusion
Software Operation (Based on Review of Error Logs) Errors in runtime log not observed	18 Participants
Software Operation (Based on Review of Error Logs) Errors in runtime log observed	1 Participants
Software Operation (Based on Review of Error Logs) Did not begin protocol	1 Participants

SECONDARY outcome

Timeframe: up to 8 hours

Population: Out of the 20 total patient-subjects, 2 subjects did not begin the protocol which leaves n=18 for the analysis population.

Median percentage (%) of time, per patient, during the session when inclusion criteria were otherwise met that the BP forecast was operative (i.e., time intervals when no InOp criteria detected by the System leading to the InOp state)

Outcome measures

Measure	Intervention Group n=18 Participants The investigational system will be evaluated for safety and user acceptance in 20 patient-subjects and associated nurse-subjects VIGORIS Blood Pressure Management Clinical Decision Support System: Software system to optimize tight blood pressure management during vasopressor infusion
Percentage of Time That the BP Forecast is Operative (Outcome 2.1)	89.3 Percentage of time Interval 86.0 to 92.9

SECONDARY outcome

Timeframe: Up to 8 hours

Population: Out of the 20 total patient-subjects, 2 subjects did not begin the protocol which leaves n=18 for the analysis population.

Accuracy of the future 20 min median MAP forecast (average error between the MAP forecast and the future 20 min median MAP; for purposes of computing future 20 min median MAP, MAP < 10 mmHg and MAP > 250 mmHg is treated as a missing number) over time intervals during the session when inclusion criteria were otherwise met; the BP forecast was operative; and the analysis window criteria were met [at least 19 minutes remaining to the end of the record from the time of the forecast; and the analysis window has no more than 9 min of non-physiological MAP data (non-physiological MAP criteria are MAP < 10mmHg or MAP > 250mmHg or 'NaN')].

Outcome measures

Measure	Intervention Group n=18 Participants The investigational system will be evaluated for safety and user acceptance in 20 patient-subjects and associated nurse-subjects VIGORIS Blood Pressure Management Clinical Decision Support System: Software system to optimize tight blood pressure management during vasopressor infusion
Accuracy of the MAP Forecast (Outcome 2.2)	0.2 mmHg Interval -9.3 to 9.7

SECONDARY outcome

Timeframe: Up to 8 hours

Population: Out of the 20 total patient-subjects, 2 subjects did not begin the protocol which leaves n=18 for the analysis population.

Median percentage (%) of time, per patient, that the true future 20 min median MAP falls within the computed forecast cone over time intervals during the session when inclusion criteria were otherwise met; the BP forecast was operative; and the analysis window criteria were met [at least 19 minutes remaining to the end of the record from the time of the forecast; and the analysis window has no more than 9 min of non-physiological MAP data (non-physiological MAP criteria are MAP < 10mmHg or MAP > 250mmHg or 'NaN')]

Outcome measures

Measure	Intervention Group n=18 Participants The investigational system will be evaluated for safety and user acceptance in 20 patient-subjects and associated nurse-subjects VIGORIS Blood Pressure Management Clinical Decision Support System: Software system to optimize tight blood pressure management during vasopressor infusion
Percentage of Time That the True Future 20 Min Median MAP Falls Within the Forecast Cone (Outcome 2.3)	99.4 Percentage of time Interval 97.0 to 100.0

SECONDARY outcome

Timeframe: Up to 8 hours

Population: Out of the 20 total patient-subjects, 2 subjects did not begin the protocol which leaves n=18 for the analysis population.

SHE incidence per 24 hrs [Sustained hypotensive event "SHE" is any interval commencing upon MAP < goal & 20-min future median MAP is also < goal; terminating upon time point when MAP >= goal and & 20-min future median MAP >= goal; SHEs occurring sequentially within 10 min are merged; any remaining SHEs not persisting at least 10 min are excluded]. [Clarification: We are reporting the mean "events per patient-day" as the Unit of Measure. Different subjects were observed for different intervals of time, with a maximum 8 hours specified in the protocol. Because subjects were observed for different time intervals, it is helpful to standardize findings as events per unit of time. Standardizing the events to units of time allows for valid inter-subject comparison when subjects have differing observation intervals. Next, events per DAY is a conventional Unit of Measurement that is both valid and easy to interpret, even though subjects were not observed for an entire day.]

Outcome measures

Measure	Intervention Group n=18 Participants The investigational system will be evaluated for safety and user acceptance in 20 patient-subjects and associated nurse-subjects VIGORIS Blood Pressure Management Clinical Decision Support System: Software system to optimize tight blood pressure management during vasopressor infusion
SHE Incidence (Outcome 3.1)	4.2 Events per patient-day (24 hours)

SECONDARY outcome

Timeframe: Up to 8 hours

Population: Out of the 20 total patient-subjects, 2 subjects did not begin the protocol which leaves n=18 for the analysis population.

Percentage (%) of total SHEs predicted by an SHE-contiguous notification event (i.e., Index > 35%) prior to the SHE's earliest hypotension [hypotension is defined as MAP < goal, with the exclusion of MAP < 10 mmHg, which is treated as a missing number]. Notification events are intervals that begin when there is an Index value that meets the notification criteria and terminate when there is an Index value output that does not meet the notification criteria.

Outcome measures

Measure	Intervention Group n=13 Sustained hypotensive events (SHE) The investigational system will be evaluated for safety and user acceptance in 20 patient-subjects and associated nurse-subjects VIGORIS Blood Pressure Management Clinical Decision Support System: Software system to optimize tight blood pressure management during vasopressor infusion
Percentage of Total SHEs Predicted by {Index > 35%} Prior to Earliest Hypotension (Outcome 3.2.1)	69.2 Percentage of total SHE events

SECONDARY outcome

Timeframe: Up to 8 hours

Population: Out of the 20 total patient-subjects, 2 subjects did not begin the protocol which leaves n=18 for the analysis population.

AWTs (median) for SHEs predicted by an SHE-contiguous notification event (i.e., Index > 35%) prior to the SHE's earliest hypotension [i.e., MAP < goal]. NOTE: A positive AWT denotes a notification event that occurs chronologically in advance of the onset of the SHE event. For example, an AWT of +3 would mean the first notification event occurred 3 minutes before the onset of the SHE event.

Outcome measures

Measure	Intervention Group n=13 Sustained hypotensive events (SHE) The investigational system will be evaluated for safety and user acceptance in 20 patient-subjects and associated nurse-subjects VIGORIS Blood Pressure Management Clinical Decision Support System: Software system to optimize tight blood pressure management during vasopressor infusion
Advance Warning Times (AWTs) for SHEs Predicted by {Index > 35%} Prior to Earliest Hypotension (Outcome 3.2.2)	6.8 Minutes Interval 1.5 to 55.3

SECONDARY outcome

Timeframe: Up to 8 hours

Population: Out of the 20 total patient-subjects, 2 subjects did not begin the protocol which leaves n=18 for the analysis population.

Percentage (%) of total SHEs predicted by an SHE-contiguous notification event (i.e., Index > user's Index threshold setting) prior to the SHE's earliest hypotension [i.e., MAP < goal]

Outcome measures

Measure	Intervention Group n=13 Sustained hypotensive events (SHE) The investigational system will be evaluated for safety and user acceptance in 20 patient-subjects and associated nurse-subjects VIGORIS Blood Pressure Management Clinical Decision Support System: Software system to optimize tight blood pressure management during vasopressor infusion
Percentage of Total SHEs Predicted by {Index > User's Index Threshold Setting} Prior to Earliest Hypotension (Outcome 3.2.3)	69.2 Percentage of total SHE events

SECONDARY outcome

Timeframe: Up to 8 hours

Population: Out of the 20 total patient-subjects, 2 subjects did not begin the protocol which leaves n=18 for the analysis population.

AWTs for SHEs predicted by an SHE-contiguous notification event (i.e., Index > user's Index threshold setting) prior to the SHE's earliest hypotension [i.e., MAP < goal]. NOTE: A positive AWT denotes a notification event that occurs chronologically in advance of the onset of the SHE event. For example, an AWT of +3 would mean the first notification event occurred 3 minutes before the onset of the SHE event.

Outcome measures

Measure	Intervention Group n=13 Sustained hypotensive events (SHE) The investigational system will be evaluated for safety and user acceptance in 20 patient-subjects and associated nurse-subjects VIGORIS Blood Pressure Management Clinical Decision Support System: Software system to optimize tight blood pressure management during vasopressor infusion
AWTs for SHEs Predicted by {Index > User's Index Threshold Setting} Prior to Earliest Hypotension (Outcome 3.2.4)	6.8 Minutes Interval 1.5 to 55.3

SECONDARY outcome

Timeframe: Up to 8 hours

Population: Out of the 20 total patient-subjects, 2 subjects did not begin the protocol which leaves n=18 for the analysis population.

Percentage (%) of total SHEs predicted by an SHE-contiguous notification event (i.e., Index > 35%) prior to continuous hypotension [intervals of ≥ 10 minutes of physiological MAP continuously below the hypotension threshold (physiological MAP are samples that do not meet the non-physiological criteria)]. NOTE: excluding SHEs predicted prior to earliest hypotension

Outcome measures

Measure	Intervention Group n=13 Sustained hypotensive events (SHE) The investigational system will be evaluated for safety and user acceptance in 20 patient-subjects and associated nurse-subjects VIGORIS Blood Pressure Management Clinical Decision Support System: Software system to optimize tight blood pressure management during vasopressor infusion
Percentage of Total SHEs Predicted by {Index > 35%} Prior to Continuous Hypotension (Outcome 3.3.1)	30.8 Percentage of total SHE events

SECONDARY outcome

Timeframe: Up to 8 hours

Population: Out of the 20 total patient-subjects, 2 subjects did not begin the protocol which leaves n=18 for the analysis population.

AWTs for SHEs predicted by an SHE-contiguous notification event (i.e., Index > 35%) prior to continuous hypotension and excluding SHEs predicted prior to earliest hypotension. NOTE: A negative AWT denotes a notification event that occurs chronologically after the onset of the SHE event. For example, an AWT of -3 would mean the first notification event occurred 3 minutes after the onset of the SHE event, although still in advance of continuous hypotension.

Outcome measures

Measure	Intervention Group n=13 Sustained hypotensive events (SHE) The investigational system will be evaluated for safety and user acceptance in 20 patient-subjects and associated nurse-subjects VIGORIS Blood Pressure Management Clinical Decision Support System: Software system to optimize tight blood pressure management during vasopressor infusion
AWTs for SHEs Predicted by {Index > 35%} Prior to Continuous Hypotension (Outcome 3.3.2)	-2.9 Minutes Interval -3.8 to -1.9

SECONDARY outcome

Timeframe: Up to 8 hours

Population: Out of the 20 total patient-subjects, 2 subjects did not begin the protocol which leaves n=18 for the analysis population.

Percentage (%) of total SHEs predicted by an SHE-contiguous notification event (i.e., Index > user's Index threshold setting) prior to continuous hypotension [intervals of ≥ 10 minutes of physiological MAP continuously below the hypotension threshold (physiological MAP are samples that do not meet the non-physiological criteria)]. NOTE: excluding SHEs predicted prior to earliest hypotension

Outcome measures

Measure	Intervention Group n=13 Sustained hypotensive events (SHE) The investigational system will be evaluated for safety and user acceptance in 20 patient-subjects and associated nurse-subjects VIGORIS Blood Pressure Management Clinical Decision Support System: Software system to optimize tight blood pressure management during vasopressor infusion
Percentage of Total SHEs Predicted by {Index > User's Index Threshold Setting} Prior to Continuous Hypotension (Outcome 3.3.3)	30.8 Percentage of total SHE events

SECONDARY outcome

Timeframe: Up to 8 hours

Population: Out of the 20 total patient-subjects, 2 subjects did not begin the protocol which leaves n=18 for the analysis population.

AWTs for SHEs predicted by an SHE-contiguous notification event (i.e., Index > user's Index threshold setting) prior to continuous hypotension and excluding SHEs predicted prior to earliest hypotension. NOTE: A negative AWT denotes a notification event that occurs chronologically after the onset of the SHE event. For example, an AWT of -3 would mean the first notification event occurred 3 minutes after the onset of the SHE event, although still in advance of continuous hypotension.

Outcome measures

Measure	Intervention Group n=13 Sustained hypotensive events (SHE) The investigational system will be evaluated for safety and user acceptance in 20 patient-subjects and associated nurse-subjects VIGORIS Blood Pressure Management Clinical Decision Support System: Software system to optimize tight blood pressure management during vasopressor infusion
AWTs for SHEs Predicted by {Index > User's Index Threshold Setting} Prior to Continuous Hypotension (Outcome 3.3.4)	-3.8 Minutes Interval -5.0 to -2.4

SECONDARY outcome

Timeframe: Up to 8 hours

Population: Out of the 20 total patient-subjects, 2 subjects did not begin the protocol which leaves n=18 for the analysis population.

Percentage (%) of total SHEs predicted by an SHE-contiguous notification event (i.e., Index > 35%) after onset of continuous hypotension

Outcome measures

Measure	Intervention Group n=13 Sustained hypotensive events (SHE) The investigational system will be evaluated for safety and user acceptance in 20 patient-subjects and associated nurse-subjects VIGORIS Blood Pressure Management Clinical Decision Support System: Software system to optimize tight blood pressure management during vasopressor infusion
Percentage of Total SHEs Detected by {Index > 35%} After Continuous Hypotension Onset (Outcome 3.4.1)	0.0 Percentage of total SHE events

SECONDARY outcome

Timeframe: Up to 8 hours

Population: Out of the 20 total patient-subjects, 2 subjects did not begin the protocol which leaves n=18 for the analysis population.

AWTs for SHEs predicted by an SHE-contiguous notification event (i.e., Index > 35%) after onset of continuous hypotension. NOTE: A positive AWT denotes a notification event that occurs chronologically in advance of the onset of the SHE event. For example, an AWT of +3 would mean the first notification event occurred 3 minutes before the onset of the SHE event.

Outcome measures

Measure	Intervention Group n=13 Sustained hypotensive events (SHE) The investigational system will be evaluated for safety and user acceptance in 20 patient-subjects and associated nurse-subjects VIGORIS Blood Pressure Management Clinical Decision Support System: Software system to optimize tight blood pressure management during vasopressor infusion
AWTs for SHEs Predicted by {Index > 35%} After Continuous Hypotension Onset (Outcome 3.4.2)	NA Minutes There were no SHE events predicted by a SHE-contiguous notification event (i.e., Index \> 35%) after onset of continuous hypotension, thus AWT is N/A.

SECONDARY outcome

Timeframe: Up to 8 hours

Population: Out of the 20 total patient-subjects, 2 subjects did not begin the protocol which leaves n=18 for the analysis population.

Percentage (%) of total SHEs predicted by an SHE-contiguous notification event (i.e., Index > user's Index threshold setting) after onset of continuous hypotension

Outcome measures

Measure	Intervention Group n=13 Sustained hypotensive events (SHE) The investigational system will be evaluated for safety and user acceptance in 20 patient-subjects and associated nurse-subjects VIGORIS Blood Pressure Management Clinical Decision Support System: Software system to optimize tight blood pressure management during vasopressor infusion
Percentage of Total SHEs Detected by {Index > User's Index Threshold Setting} After Continuous Hypotension Onset (Outcome 3.4.3)	0.0 Percentage of total SHE events

SECONDARY outcome

Timeframe: Up to 8 hours

Population: Out of the 20 total patient-subjects, 2 subjects did not begin the protocol which leaves n=18 for the analysis population.

AWTs for SHEs predicted by an SHE-contiguous notification event (i.e., Index > user's Index threshold setting) after onset of continuous hypotension. NOTE: A positive AWT denotes a notification event that occurs chronologically in advance of the onset of the SHE event. For example, an AWT of +3 would mean the first notification event occurred 3 minutes before the onset of the SHE event.

Outcome measures

Measure	Intervention Group n=13 Sustained hypotensive events (SHE) The investigational system will be evaluated for safety and user acceptance in 20 patient-subjects and associated nurse-subjects VIGORIS Blood Pressure Management Clinical Decision Support System: Software system to optimize tight blood pressure management during vasopressor infusion
AWTs for SHEs Predicted by {Index > User's Index Threshold Setting} After Continuous Hypotension Onset (Outcome 3.4.4)	NA Minutes There were no SHE events predicted by a SHE-contiguous notification event (i.e., Index \> user's Index threshold setting) after onset of continuous hypotension, thus AWT is N/A.

SECONDARY outcome

Timeframe: Up to 8 hours

Population: Out of the 20 total patient-subjects, 2 subjects did not begin the protocol which leaves n=18 for the analysis population.

Percentage of total SHEs with false resolutions [i.e., MAP >= goal transiently during SHE]

Outcome measures

Measure	Intervention Group n=13 Sustained hypotensive events (SHE) The investigational system will be evaluated for safety and user acceptance in 20 patient-subjects and associated nurse-subjects VIGORIS Blood Pressure Management Clinical Decision Support System: Software system to optimize tight blood pressure management during vasopressor infusion
Percentage of Total SHEs With False Resolutions (Outcome 3.5.1)	100.0 Percentage of total SHE events

SECONDARY outcome

Timeframe: Up to 8 hours

Population: Out of the 20 total patient-subjects, 2 subjects did not begin the protocol which leaves n=18 for the analysis population.

Percentage (%) of total SHE false resolutions with a contiguous notification event where {Index > 35%}

Outcome measures

Measure	Intervention Group n=354 SHE false resolutions The investigational system will be evaluated for safety and user acceptance in 20 patient-subjects and associated nurse-subjects VIGORIS Blood Pressure Management Clinical Decision Support System: Software system to optimize tight blood pressure management during vasopressor infusion
Percentage of Total SHE False Resolutions Detected by {Index > 35%} (Outcome 3.5.2)	96.3 Percentage of total false resolutions

SECONDARY outcome

Timeframe: Up to 8 hours

Population: Out of the 20 total patient-subjects, 2 subjects did not begin the protocol which leaves n=18 for the analysis population.

Percentage of total SHE false resolutions that were not detected by {Index > 35%} and had InOp state occurring during the index false resolution episode

Outcome measures

Measure	Intervention Group n=354 SHE false resolutions The investigational system will be evaluated for safety and user acceptance in 20 patient-subjects and associated nurse-subjects VIGORIS Blood Pressure Management Clinical Decision Support System: Software system to optimize tight blood pressure management during vasopressor infusion
Percentage of Total SHE False Resolutions Not Detected by {Index > 35%} With InOp State During False Resolution (Outcome 3.5.3)	0.3 Percentage of total false resolutions

SECONDARY outcome

Timeframe: Up to 8 hours

Population: Out of the 20 total patient-subjects, 2 subjects did not begin the protocol which leaves n=18 for the analysis population.

Percentage (%) of total SHE false resolutions that were not detected by {Index > 35%} and did not have InOp state occurring during the index false resolution episode

Outcome measures

Measure	Intervention Group n=354 SHE false resolutions The investigational system will be evaluated for safety and user acceptance in 20 patient-subjects and associated nurse-subjects VIGORIS Blood Pressure Management Clinical Decision Support System: Software system to optimize tight blood pressure management during vasopressor infusion
Percentage of Total SHE False Resolutions Not Detected by {Index > 35%} Without InOp State During False Resolution (Outcome 3.5.4)	3.4 Percentage of total false resolutions

SECONDARY outcome

Timeframe: Up to 8 hours

Population: Out of the 20 total patient-subjects, 2 subjects did not begin the protocol which leaves n=18 for the analysis population.

Percentage (%) of total SHE false resolutions with a contiguous notification event where {Index > user's Index threshold setting}

Outcome measures

Measure	Intervention Group n=354 SHE false resolutions The investigational system will be evaluated for safety and user acceptance in 20 patient-subjects and associated nurse-subjects VIGORIS Blood Pressure Management Clinical Decision Support System: Software system to optimize tight blood pressure management during vasopressor infusion
Percentage of Total SHE False Resolutions Detected by {Index > User's Index Threshold Setting} (Outcome 3.5.5)	95.2 Percentage of total false resolutions

SECONDARY outcome

Timeframe: Up to 8 hours

Population: Out of the 20 total patient-subjects, 2 subjects did not begin the protocol which leaves n=18 for the analysis population.

Percentage (%) of total SHE false resolutions that were not detected by {Index > user's Index threshold setting} and had InOp state occurring during the index false resolution episode

Outcome measures

Measure	Intervention Group n=354 SHE false resolutions The investigational system will be evaluated for safety and user acceptance in 20 patient-subjects and associated nurse-subjects VIGORIS Blood Pressure Management Clinical Decision Support System: Software system to optimize tight blood pressure management during vasopressor infusion
Percentage of Total SHE False Resolutions Not Detected by {Index > User's Index Threshold Setting} With InOp State During False Resolution (Outcome 3.5.6)	0.3 Percentage of total false resolutions

SECONDARY outcome

Timeframe: Up to 8 hours

Population: Out of the 20 total patient-subjects, 2 subjects did not begin the protocol which leaves n=18 for the analysis population.

Percentage (%) of total SHE false resolutions that were not detected by {Index > user's Index threshold setting} and did not have InOp state occurring during the index false resolution episode

Outcome measures

Measure	Intervention Group n=354 SHE false resolutions The investigational system will be evaluated for safety and user acceptance in 20 patient-subjects and associated nurse-subjects VIGORIS Blood Pressure Management Clinical Decision Support System: Software system to optimize tight blood pressure management during vasopressor infusion
Percentage of Total SHE False Resolutions Not Detected by {Index > User's Index Threshold Setting} Without InOp State During False Resolution (Outcome 3.5.7)	4.5 Percentage of total false resolutions

SECONDARY outcome

Timeframe: Up to 8 hours

Population: Out of the 20 total patient-subjects, 2 subjects did not begin the protocol which leaves n=18 for the analysis population.

Incidence of notification events {Index > 35%} that are contiguous with SHEs, excluding notification events with onset during an SHE. [Clarification: We are reporting the mean "notification events / patient-day (24h)" as the Unit of Measure. Different subjects were observed for different intervals of time, with a maximum 8 hours specified in the protocol. Because subjects were observed for different time intervals, it is helpful to standardize findings as events per unit of time. Standardizing the events to units of time allows for valid inter-subject comparison when subjects have differing observation intervals. Next, events per DAY is a conventional Unit of Measurement that is both valid and easy to interpret, even though subjects were not observed for an entire day.]

Outcome measures

Measure	Intervention Group n=18 Participants The investigational system will be evaluated for safety and user acceptance in 20 patient-subjects and associated nurse-subjects VIGORIS Blood Pressure Management Clinical Decision Support System: Software system to optimize tight blood pressure management during vasopressor infusion
Incidence of Notification Events {Index > 35%} That Are Contiguous With SHEs (Outcome 3.6.1)	2.3 Notification events / patient-day (24h)

SECONDARY outcome

Timeframe: Up to 8 hours

Population: Out of the 20 total patient-subjects, 2 subjects did not begin the protocol which leaves n=18 for the analysis population.

Incidence of notification events {Index > user's Index threshold setting} that are contiguous with SHEs, excluding notification events with onset during an SHE. [Clarification: We are reporting the mean "notification events / patient-day (24h)" as the Unit of Measure. Different subjects were observed for different intervals of time, with a maximum 8 hours specified in the protocol. Because subjects were observed for different time intervals, it is helpful to standardize findings as events per unit of time. Standardizing the events to units of time allows for valid inter-subject comparison when subjects have differing observation intervals. Next, events per DAY is a conventional Unit of Measurement that is both valid and easy to interpret, even though subjects were not observed for an entire day.]

Outcome measures

Measure	Intervention Group n=18 Participants The investigational system will be evaluated for safety and user acceptance in 20 patient-subjects and associated nurse-subjects VIGORIS Blood Pressure Management Clinical Decision Support System: Software system to optimize tight blood pressure management during vasopressor infusion
Incidence of Notification Events {Index > User's Index Threshold Setting} That Are Contiguous With SHEs (Outcome 3.6.2)	2.3 Notification events / patient-day (24h)

SECONDARY outcome

Timeframe: Up to 8 hours

Population: Out of the 20 total patient-subjects, 2 subjects did not begin the protocol which leaves n=18 for the analysis population.

Incidence of notification events {Index > 35%} that are sentinel notifications [sentinel notification is a notification event that occurs within 60 min prior to an SHE; recorded dose increase; or during stuttering hypotension (defined in 3.7.1)], excluding notification events with onset during an SHE. [Clarification: We are reporting the mean "notification events / patient-day (24h)" as the Unit of Measure. Different subjects were observed for different intervals of time, with a maximum 8 hours specified in the protocol. Because subjects were observed for different time intervals, it is helpful to standardize findings as events per unit of time. Standardizing the events to units of time allows for valid inter-subject comparison when subjects have differing observation intervals. Next, events per DAY is a conventional Unit of Measurement that is both valid and easy to interpret, even though subjects were not observed for an entire day.]

Outcome measures

Measure	Intervention Group n=18 Participants The investigational system will be evaluated for safety and user acceptance in 20 patient-subjects and associated nurse-subjects VIGORIS Blood Pressure Management Clinical Decision Support System: Software system to optimize tight blood pressure management during vasopressor infusion
Incidence of Notification Events {Index > 35%} That Are Sentinel Notifications (Outcome 3.6.3)	7.8 Notification events / patient-day (24h)

SECONDARY outcome

Timeframe: Up to 8 hours

Population: Out of the 20 total patient-subjects, 2 subjects did not begin the protocol which leaves n=18 for the analysis population.

Incidence of notification events {Index > user's Index threshold setting} that are sentinel notifications, excluding notification events with onset during an SHE. [Clarification: We are reporting the mean "notification events / patient-day (24h)" as the Unit of Measure. Different subjects were observed for different intervals of time, with a maximum 8 hours specified in the protocol. Because subjects were observed for different time intervals, it is helpful to standardize findings as events per unit of time. Standardizing the events to units of time allows for valid inter-subject comparison when subjects have differing observation intervals. Next, events per DAY is a conventional Unit of Measurement that is both valid and easy to interpret, even though subjects were not observed for an entire day.]

Outcome measures

Measure	Intervention Group n=18 Participants The investigational system will be evaluated for safety and user acceptance in 20 patient-subjects and associated nurse-subjects VIGORIS Blood Pressure Management Clinical Decision Support System: Software system to optimize tight blood pressure management during vasopressor infusion
Incidence of Notification Events {Index > User's Index Threshold Setting} That Are Sentinel Notifications (Outcome 3.6.4)	7.1 Notification events / patient-day (24h)

SECONDARY outcome

Timeframe: Up to 8 hours

Population: Out of the 20 total patient-subjects, 2 subjects did not begin the protocol which leaves n=18 for the analysis population.

Incidence of notification events {Index > 35%} that are false notifications (defined as notification events not contiguous with an SHE and not a sentinel notification, excluding notification events with onset during an SHE. [Clarification: We are reporting the mean "notification events / patient-day (24h)" as the Unit of Measure. Different subjects were observed for different intervals of time, with a maximum 8 hours specified in the protocol. Because subjects were observed for different time intervals, it is helpful to standardize findings as events per unit of time. Standardizing the events to units of time allows for valid inter-subject comparison when subjects have differing observation intervals. Next, events per DAY is a conventional Unit of Measurement that is both valid and easy to interpret, even though subjects were not observed for an entire day.]

Outcome measures

Measure	Intervention Group n=18 Participants The investigational system will be evaluated for safety and user acceptance in 20 patient-subjects and associated nurse-subjects VIGORIS Blood Pressure Management Clinical Decision Support System: Software system to optimize tight blood pressure management during vasopressor infusion
Incidence of Notification Events {Index > 35%} That Are False Notifications (Outcome 3.6.5)	10.0 Notification events / patient-day (24h)

SECONDARY outcome

Timeframe: Up to 8 hours

Population: Out of the 20 total patient-subjects, 2 subjects did not begin the protocol which leaves n=18 for the analysis population.

Incidence of notification events {Index > user's Index threshold setting} that are false notifications. [Clarification: We are reporting the mean "notification events / patient-day (24h)" as the Unit of Measure. Different subjects were observed for different intervals of time, with a maximum 8 hours specified in the protocol. Because subjects were observed for different time intervals, it is helpful to standardize findings as events per unit of time. Standardizing the events to units of time allows for valid inter-subject comparison when subjects have differing observation intervals. Next, events per DAY is a conventional Unit of Measurement that is both valid and easy to interpret, even though subjects were not observed for an entire day.]

Outcome measures

Measure	Intervention Group n=18 Participants The investigational system will be evaluated for safety and user acceptance in 20 patient-subjects and associated nurse-subjects VIGORIS Blood Pressure Management Clinical Decision Support System: Software system to optimize tight blood pressure management during vasopressor infusion
Incidence of Notification Events {Index > User's Index Threshold Setting} That Are False Notifications (Outcome 3.6.6)	10.7 Notification events / patient-day (24h)

SECONDARY outcome

Timeframe: Up to 8 hours

Population: Out of the 20 total patient-subjects, 2 subjects did not begin the protocol which leaves n=18 for the analysis population.

Incidence of notification events {Index > 35%} contiguous with an SHE false resolution. [Clarification: We are reporting the mean "notification events / patient-day (24h)" as the Unit of Measure. Different subjects were observed for different intervals of time, with a maximum 8 hours specified in the protocol. Because subjects were observed for different time intervals, it is helpful to standardize findings as events per unit of time. Standardizing the events to units of time allows for valid inter-subject comparison when subjects have differing observation intervals. Next, events per DAY is a conventional Unit of Measurement that is both valid and easy to interpret, even though subjects were not observed for an entire day.]

Outcome measures

Measure	Intervention Group n=18 Participants The investigational system will be evaluated for safety and user acceptance in 20 patient-subjects and associated nurse-subjects VIGORIS Blood Pressure Management Clinical Decision Support System: Software system to optimize tight blood pressure management during vasopressor infusion
Incidence of Notification Events {Index > 35%} Contiguous With an SHE False Resolution (Outcome 3.6.7)	3.2 Notification events / patient-day (24h)

SECONDARY outcome

Timeframe: Up to 8 hours

Population: Out of the 20 total patient-subjects, 2 subjects did not begin the protocol which leaves n=18 for the analysis population.

Incidence of notification events {Index > user's Index threshold setting} contiguous with an SHE false resolution. [Clarification: We are reporting the mean "notification events / patient-day (24h)" as the Unit of Measure. Different subjects were observed for different intervals of time, with a maximum 8 hours specified in the protocol. Because subjects were observed for different time intervals, it is helpful to standardize findings as events per unit of time. Standardizing the events to units of time allows for valid inter-subject comparison when subjects have differing observation intervals. Next, events per DAY is a conventional Unit of Measurement that is both valid and easy to interpret, even though subjects were not observed for an entire day.]

Outcome measures

Measure	Intervention Group n=18 Participants The investigational system will be evaluated for safety and user acceptance in 20 patient-subjects and associated nurse-subjects VIGORIS Blood Pressure Management Clinical Decision Support System: Software system to optimize tight blood pressure management during vasopressor infusion
Incidence of Notification Events {Index > User's Index Threshold Setting} Contiguous With an SHE False Resolution (Outcome 3.6.8)	3.6 Notification events / patient-day (24h)

SECONDARY outcome

Timeframe: Up to 8 hours

Population: Out of the 20 total patient-subjects, 2 subjects did not begin the protocol which leaves n=18 for the analysis population.

Incidence of notification events {Index > 35%} contiguous with an SHE true resolution. [Clarification: We are reporting the mean "notification events / patient-day (24h)" as the Unit of Measure. Different subjects were observed for different intervals of time, with a maximum 8 hours specified in the protocol. Because subjects were observed for different time intervals, it is helpful to standardize findings as events per unit of time. Standardizing the events to units of time allows for valid inter-subject comparison when subjects have differing observation intervals. Next, events per DAY is a conventional Unit of Measurement that is both valid and easy to interpret, even though subjects were not observed for an entire day.]

Outcome measures

Measure	Intervention Group n=18 Participants The investigational system will be evaluated for safety and user acceptance in 20 patient-subjects and associated nurse-subjects VIGORIS Blood Pressure Management Clinical Decision Support System: Software system to optimize tight blood pressure management during vasopressor infusion
Incidence of Notification Events {Index > 35%} Contiguous With an SHE True Resolution, Overall (Outcome 3.6.9)	3.6 Notification events / patient-day (24h)

SECONDARY outcome

Timeframe: Up to 8 hours

Population: Out of the 20 total patient-subjects, 2 subjects did not begin the protocol which leaves n=18 for the analysis population.

Incidence of notification events {Index > user's Index threshold setting} contiguous with an SHE true resolution. [Clarification: We are reporting the mean "notification events / patient-day (24h)" as the Unit of Measure. Different subjects were observed for different intervals of time, with a maximum 8 hours specified in the protocol. Because subjects were observed for different time intervals, it is helpful to standardize findings as events per unit of time. Standardizing the events to units of time allows for valid inter-subject comparison when subjects have differing observation intervals. Next, events per DAY is a conventional Unit of Measurement that is both valid and easy to interpret, even though subjects were not observed for an entire day.]

Outcome measures

Measure	Intervention Group n=18 Participants The investigational system will be evaluated for safety and user acceptance in 20 patient-subjects and associated nurse-subjects VIGORIS Blood Pressure Management Clinical Decision Support System: Software system to optimize tight blood pressure management during vasopressor infusion
Incidence of Notification Events {Index > User's Index Threshold Setting} Contiguous With an SHE True Resolution, Overall (Outcome 3.6.10)	3.6 Notification events / patient-day (24h)

SECONDARY outcome

Timeframe: Up to 8 hours

Population: Out of the 20 total patient-subjects, 2 subjects did not begin the protocol which leaves n=18 for the analysis population.

Incidence of notification events {Index > 35%} contiguous with an SHE true resolution after excluding all notification event interval that were within 8 min of a documented clinical intervention. [Clarification: We are reporting the mean "notification events / patient-day (24h)" as the Unit of Measure. Different subjects were observed for different intervals of time, with a maximum 8 hours specified in the protocol. Because subjects were observed for different time intervals, it is helpful to standardize findings as events per unit of time. Standardizing the events to units of time allows for valid inter-subject comparison when subjects have differing observation intervals. Next, events per DAY is a conventional Unit of Measurement that is both valid and easy to interpret, even though subjects were not observed for an entire day.]

Outcome measures

Measure	Intervention Group n=18 Participants The investigational system will be evaluated for safety and user acceptance in 20 patient-subjects and associated nurse-subjects VIGORIS Blood Pressure Management Clinical Decision Support System: Software system to optimize tight blood pressure management during vasopressor infusion
Incidence of Notification Events {Index > 35%} Contiguous With an SHE True Resolution, Suppressible (Outcome 3.6.11)	0.7 Notification events / patient-day (24h)

SECONDARY outcome

Timeframe: Up to 8 hours

Population: Out of the 20 total patient-subjects, 2 subjects did not begin the protocol which leaves n=18 for the analysis population.

Incidence of notification events {Index > user's Index threshold setting} contiguous with an SHE true resolution after excluding all notification event interval that were within 8 min of a documented clinical intervention. [Clarification: We are reporting the mean "notification events / patient-day (24h)" as the Unit of Measure. Different subjects were observed for different intervals of time, with a maximum 8 hours specified in the protocol. Because subjects were observed for different time intervals, it is helpful to standardize findings as events per unit of time. Standardizing the events to units of time allows for valid inter-subject comparison when subjects have differing observation intervals. Next, events per DAY is a conventional Unit of Measurement that is both valid and easy to interpret, even though subjects were not observed for an entire day.]

Outcome measures

Measure	Intervention Group n=18 Participants The investigational system will be evaluated for safety and user acceptance in 20 patient-subjects and associated nurse-subjects VIGORIS Blood Pressure Management Clinical Decision Support System: Software system to optimize tight blood pressure management during vasopressor infusion
Incidence of Notification Events {Index > User's Index Threshold Setting} Contiguous With an SHE True Resolution, Suppressible (Outcome 3.6.12)	0.7 Notification events / patient-day (24h)

SECONDARY outcome

Timeframe: Up to 8 hours

Population: Out of the 20 total patient-subjects, 2 subjects did not begin the protocol which leaves n=18 for the analysis population.

Incidence of notification events {Index > 35%} with onset during an SHE. [Clarification: We are reporting the mean "notification events / patient-day (24h)" as the Unit of Measure. Different subjects were observed for different intervals of time, with a maximum 8 hours specified in the protocol. Because subjects were observed for different time intervals, it is helpful to standardize findings as events per unit of time. Standardizing the events to units of time allows for valid inter-subject comparison when subjects have differing observation intervals. Next, events per DAY is a conventional Unit of Measurement that is both valid and easy to interpret, even though subjects were not observed for an entire day.]

Outcome measures

Measure	Intervention Group n=18 Participants The investigational system will be evaluated for safety and user acceptance in 20 patient-subjects and associated nurse-subjects VIGORIS Blood Pressure Management Clinical Decision Support System: Software system to optimize tight blood pressure management during vasopressor infusion
Incidence of Notification Events {Index > 35%} With Onset During an SHE (Outcome 3.6.13)	1.3 Notification events / patient-day (24h)

SECONDARY outcome

Timeframe: Up to 8 hours

Population: Out of the 20 total patient-subjects, 2 subjects did not begin the protocol which leaves n=18 for the analysis population.

Incidence of notification events {Index > user's Index threshold setting} with onset during an SHE. [Clarification: We are using "notification events / patient-day (24h)" as the Unit of Measure for several reasons. First, different subjects were observed for different intervals of time, with a maximum 8 hours specified in the protocol. Because subjects were observed for different time intervals, it is helpful to standardize findings as events per unit of time. Standardizing the events to units of time allows for valid inter-subject comparison when subjects have differing observation intervals. Next, events per DAY is a conventional Unit of Measurement that is both valid and easy to interpret, even though subjects were not observed for an entire day.]

Outcome measures

Measure	Intervention Group n=18 Participants The investigational system will be evaluated for safety and user acceptance in 20 patient-subjects and associated nurse-subjects VIGORIS Blood Pressure Management Clinical Decision Support System: Software system to optimize tight blood pressure management during vasopressor infusion
Incidence of Notification Events {Index > User's Index Threshold Setting} With Onset During an SHE (Outcome 3.6.14)	1.3 Notification events / patient-day (24h)

SECONDARY outcome

Timeframe: Up to 8 hours

Population: Out of the 20 total patient-subjects, 2 subjects did not begin the protocol which leaves n=18 for the analysis population.

Median duration of false notification events {Index > 35%}

Outcome measures

Measure	Intervention Group n=66 Notification events The investigational system will be evaluated for safety and user acceptance in 20 patient-subjects and associated nurse-subjects VIGORIS Blood Pressure Management Clinical Decision Support System: Software system to optimize tight blood pressure management during vasopressor infusion
Duration of False Notification Events {Index > 35%} (Outcome 3.6.15)	3.8 Minutes Interval 2.0 to 7.7

SECONDARY outcome

Timeframe: Up to 8 hours

Population: Out of the 20 total patient-subjects, 2 subjects did not begin the protocol which leaves n=18 for the analysis population.

Median duration of false notification events {Index > user's Index threshold setting}

Outcome measures

Measure	Intervention Group n=66 Notification events The investigational system will be evaluated for safety and user acceptance in 20 patient-subjects and associated nurse-subjects VIGORIS Blood Pressure Management Clinical Decision Support System: Software system to optimize tight blood pressure management during vasopressor infusion
Duration of False Notification Events {Index > User's Index Threshold Setting} (Outcome 3.6.16)	3.8 Minutes Interval 2.0 to 8.4

SECONDARY outcome

Timeframe: Up to 8 hours

Population: Out of the 20 total patient-subjects, 2 subjects did not begin the protocol which leaves n=18 for the analysis population.

Stuttering hypotension incidence [Stuttering hypotension event commences upon hypotension and with >= 10 min of cumulative hypotension within subsequent 60 min; terminates upon next time point when onset condition is no longer met AND when MAP >= goal; intervals that qualify as an SHE are excluded from stuttering hypotension]. [Clarification: We are reporting the mean "events per patient-day" as the Unit of Measure. Different subjects were observed for different intervals of time, with a maximum 8 hours specified in the protocol. Because subjects were observed for different time intervals, it is helpful to standardize findings as events per unit of time. Standardizing the events to units of time allows for valid inter-subject comparison when subjects have differing observation intervals. Next, events per DAY is a conventional Unit of Measurement that is both valid and easy to interpret, even though subjects were not observed for an entire day.]

Outcome measures

Measure	Intervention Group n=18 Participants The investigational system will be evaluated for safety and user acceptance in 20 patient-subjects and associated nurse-subjects VIGORIS Blood Pressure Management Clinical Decision Support System: Software system to optimize tight blood pressure management during vasopressor infusion
Stuttering Hypotension Incidence (Outcome 3.7.1)	3.2 Events per patient-day (24 hours)

SECONDARY outcome

Timeframe: Up to 8 hours

Population: Out of the 20 total patient-subjects, 2 subjects did not begin the protocol which leaves n=18 for the analysis population.

Percentage (%) of total stuttering hypotension episodes detected by {Index > 35%} prior to the stuttering hypotension's first hypotension

Outcome measures

Measure	Intervention Group n=10 Stuttering hypotension episodes The investigational system will be evaluated for safety and user acceptance in 20 patient-subjects and associated nurse-subjects VIGORIS Blood Pressure Management Clinical Decision Support System: Software system to optimize tight blood pressure management during vasopressor infusion
Percentage of Total Stuttering Hypotension Episodes Detected by {Index > 35%} Prior to the Stuttering Hypotension's First Hypotension (Outcome 3.7.2)	40.0 Percentage of total stuttering events

SECONDARY outcome

Timeframe: Up to 8 hours

Population: Out of the 20 total patient-subjects, 2 subjects did not begin the protocol which leaves n=18 for the analysis population.

AWTs for stuttering hypotension episodes detected by {Index > 35%} prior to the stuttering hypotension's first hypotension. NOTE: A positive AWT denotes a notification event that occurs chronologically in advance of the onset of the SHE event. For example, an AWT of +3 would mean the first notification event occurred 3 minutes before the onset of the SHE event.

Outcome measures

Measure	Intervention Group n=10 Stuttering hypotension episodes The investigational system will be evaluated for safety and user acceptance in 20 patient-subjects and associated nurse-subjects VIGORIS Blood Pressure Management Clinical Decision Support System: Software system to optimize tight blood pressure management during vasopressor infusion
AWTs for Stuttering Hypotension Episodes Detected by {Index > 35%} Prior to the Stuttering Hypotension's First Hypotension (Outcome 3.7.3)	1.3 Minutes Interval 0.7 to 2.0

SECONDARY outcome

Timeframe: Up to 8 hours

Population: Out of the 20 total patient-subjects, 2 subjects did not begin the protocol which leaves n=18 for the analysis population.

Percentage (%) of total stuttering hypotension episodes detected by {Index > user's Index threshold setting} prior to the stuttering hypotension's first hypotension

Outcome measures

Measure	Intervention Group n=10 Stuttering hypotension episodes The investigational system will be evaluated for safety and user acceptance in 20 patient-subjects and associated nurse-subjects VIGORIS Blood Pressure Management Clinical Decision Support System: Software system to optimize tight blood pressure management during vasopressor infusion
Percentage of Total Stuttering Hypotension Episodes Detected by {Index > User's Index Threshold Setting} Prior to the Stuttering Hypotension's First Hypotension (Outcome 3.7.4)	40.0 Percentage of total stuttering events

SECONDARY outcome

Timeframe: Up to 8 hours

Population: Out of the 20 total patient-subjects, 2 subjects did not begin the protocol which leaves n=18 for the analysis population.

AWTs for stuttering hypotension episodes detected by {Index > user's Index threshold setting} prior to the stuttering hypotension's first hypotension. NOTE: A positive AWT denotes a notification event that occurs chronologically in advance of the onset of the SHE event. For example, an AWT of +3 would mean the first notification event occurred 3 minutes before the onset of the SHE event.

Outcome measures

Measure	Intervention Group n=10 Stuttering hypotension episodes The investigational system will be evaluated for safety and user acceptance in 20 patient-subjects and associated nurse-subjects VIGORIS Blood Pressure Management Clinical Decision Support System: Software system to optimize tight blood pressure management during vasopressor infusion
AWTs for Stuttering Hypotension Episodes Detected by {Index > User's Index Threshold Setting} Prior to the Stuttering Hypotension's First Hypotension (Outcome 3.7.5)	1.3 Minutes Interval 0.7 to 2.0

SECONDARY outcome

Timeframe: Up to 8 hours

Population: Out of the 20 total patient-subjects, 2 subjects did not begin the protocol which leaves n=18 for the analysis population.

Percentage (%) of total stuttering hypotension episodes detected by {Index > 35%} prior to the occurrence of 10 cumulative minutes of hypotension within that stuttering hypotension episode (excluding episodes detected prior to first hypotension)

Outcome measures

Measure	Intervention Group n=10 Stuttering hypotension episodes The investigational system will be evaluated for safety and user acceptance in 20 patient-subjects and associated nurse-subjects VIGORIS Blood Pressure Management Clinical Decision Support System: Software system to optimize tight blood pressure management during vasopressor infusion
Percentage of Total Stuttering Hypotension Episodes Detected by {Index > 35%} Prior to 10 Cumulative Min of Hypotension (Outcome 3.7.6)	60.0 Percentage of total stuttering events

SECONDARY outcome

Timeframe: Up to 8 hours

Population: Out of the 20 total patient-subjects, 2 subjects did not begin the protocol which leaves n=18 for the analysis population.

AWTs for stuttering hypotension episodes detected by {Index > 35%} prior to 10 cumulative min of hypotension. NOTE: A positive AWT denotes a notification event that occurs chronologically in advance of the onset of the SHE event. For example, an AWT of +3 would mean the first notification event occurred 3 minutes before the onset of the SHE event.

Outcome measures

Measure	Intervention Group n=10 Stuttering hypotension episodes The investigational system will be evaluated for safety and user acceptance in 20 patient-subjects and associated nurse-subjects VIGORIS Blood Pressure Management Clinical Decision Support System: Software system to optimize tight blood pressure management during vasopressor infusion
AWTs for Stuttering Hypotension Episodes Detected by {Index > 35%} Prior to 10 Cumulative Min of Hypotension (Outcome 3.7.7)	-8.0 Minutes Interval -19.2 to -2.2

SECONDARY outcome

Timeframe: Up to 8 hours

Population: Out of the 20 total patient-subjects, 2 subjects did not begin the protocol which leaves n=18 for the analysis population.

Percentage (%) of total stuttering hypotension episodes detected by {Index > user's Index threshold setting} prior to the occurrence of 10 cumulative minutes of hypotension within that stuttering hypotension episode (excluding episodes detected prior to first hypotension)

Outcome measures

Measure	Intervention Group n=10 Stuttering hypotension episodes The investigational system will be evaluated for safety and user acceptance in 20 patient-subjects and associated nurse-subjects VIGORIS Blood Pressure Management Clinical Decision Support System: Software system to optimize tight blood pressure management during vasopressor infusion
Percentage of Total Stuttering Hypotension Episodes Detected by {Index > User's Index Threshold Setting} Prior to 10 Cumulative Min of Hypotension (Outcome 3.7.8)	60.0 Percentage of total stuttering events

SECONDARY outcome

Timeframe: Up to 8 hours

Population: Out of the 20 total patient-subjects, 2 subjects did not begin the protocol which leaves n=18 for the analysis population.

AWTs for stuttering hypotension episodes detected by {Index > user's Index threshold setting} prior to 10 cumulative min of hypotension. NOTE: A positive AWT denotes a notification event that occurs chronologically in advance of the onset of the SHE event. For example, an AWT of +3 would mean the first notification event occurred 3 minutes before the onset of the SHE event.

Outcome measures

Measure	Intervention Group n=10 Stuttering hypotension episodes The investigational system will be evaluated for safety and user acceptance in 20 patient-subjects and associated nurse-subjects VIGORIS Blood Pressure Management Clinical Decision Support System: Software system to optimize tight blood pressure management during vasopressor infusion
AWTs for Stuttering Hypotension Episodes Detected by {Index > User's Index Threshold Setting} Prior to 10 Cumulative Min of Hypotension (Outcome 3.7.9)	-8.0 Minutes Interval -19.2 to -2.2

SECONDARY outcome

Timeframe: Up to 8 hours

Population: Out of the 20 total patient-subjects, 2 subjects did not begin the protocol which leaves n=18 for the analysis population.

Percentage (%) of total stuttering hypotension episodes not detected by {Index > 35%} prior to the occurrence of 10 cumulative minutes of hypotension within that stuttering hypotension episode

Outcome measures

Measure	Intervention Group n=10 Stuttering hypotension episodes The investigational system will be evaluated for safety and user acceptance in 20 patient-subjects and associated nurse-subjects VIGORIS Blood Pressure Management Clinical Decision Support System: Software system to optimize tight blood pressure management during vasopressor infusion
Percentage of Total Stuttering Hypotension Episodes Not Detected by {Index > 35%} Prior to 10 Cumulative Min of Hypotension (Outcome 3.7.10)	0.0 Percentage of total stuttering events

SECONDARY outcome

Timeframe: Up to 8 hours

Population: Out of the 20 total patient-subjects, 2 subjects did not begin the protocol which leaves n=18 for the analysis population.

Percentage (%) of total stuttering hypotension episodes not detected by {Index > user's Index threshold setting} prior to the occurrence of 10 cumulative minutes of hypotension within that stuttering hypotension episode

Outcome measures

Measure	Intervention Group n=10 Stuttering hypotension episodes The investigational system will be evaluated for safety and user acceptance in 20 patient-subjects and associated nurse-subjects VIGORIS Blood Pressure Management Clinical Decision Support System: Software system to optimize tight blood pressure management during vasopressor infusion
Percentage of Total Stuttering Hypotension Episodes Not Detected by {Index > User's Index Threshold Setting} Prior to 10 Cumulative Min of Hypotension (Outcome 3.7.11)	0.0 Percentage of total stuttering events

Adverse Events

Intervention Group

Serious events: 9 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	Intervention Group n=20 participants at risk The investigational system will be evaluated for safety and user acceptance in 20 patient-subjects and associated nurse-subjects VIGORIS Blood Pressure Management Clinical Decision Support System: Software system to optimize tight blood pressure management during vasopressor infusion
Cardiac disorders Multi-clinician response	5.0% 1/20 • Number of events 1 • 4-8 hours (duration of investigational protocol) Adverse events (AEs) were determined systematically by a real-time technical observer; nurse-subject surveys; and the software logs. Expected AEs in a population of ICU patients on vasopressors included all sustained hypotension episodes; tachyarrhythmias (HR \> 150 bpm) or bradyarrhythmias (HR \< 50 bpm) that persist for more than ten minutes; need for chest compressions or defibrillation; or any unscheduled bedside response by the ICU care team involving more than the patient's primary nurse.
Cardiac disorders Sustained hypotensive event	45.0% 9/20 • Number of events 13 • 4-8 hours (duration of investigational protocol) Adverse events (AEs) were determined systematically by a real-time technical observer; nurse-subject surveys; and the software logs. Expected AEs in a population of ICU patients on vasopressors included all sustained hypotension episodes; tachyarrhythmias (HR \> 150 bpm) or bradyarrhythmias (HR \< 50 bpm) that persist for more than ten minutes; need for chest compressions or defibrillation; or any unscheduled bedside response by the ICU care team involving more than the patient's primary nurse.

Other adverse events

Measure

Intervention Group n=20 participants at risk The investigational system will be evaluated for safety and user acceptance in 20 patient-subjects and associated nurse-subjects VIGORIS Blood Pressure Management Clinical Decision Support System: Software system to optimize tight blood pressure management during vasopressor infusion

Investigations Unable to electronically communicate with GE monitor

5.0% 1/20 • Number of events 1 • 4-8 hours (duration of investigational protocol) Adverse events (AEs) were determined systematically by a real-time technical observer; nurse-subject surveys; and the software logs. Expected AEs in a population of ICU patients on vasopressors included all sustained hypotension episodes; tachyarrhythmias (HR \> 150 bpm) or bradyarrhythmias (HR \< 50 bpm) that persist for more than ten minutes; need for chest compressions or defibrillation; or any unscheduled bedside response by the ICU care team involving more than the patient's primary nurse.

Additional Information

Dr. Andrew Tomas Reisner

Massachusetts General Hospital

Phone: 617-726-2241

Email: areisner@mgh.harvard.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place