Trial Outcomes & Findings for Hypotension Prediction Index for Blood Pressure Management (NCT NCT03610165)
NCT ID: NCT03610165
Last Updated: 2021-05-19
Results Overview
MAP stands for mean arterial pressure. Time-weighted average MAP below 65 mmHg threshold for each patient was derived by dividing AUC-MAP by the time interval between the first and the last MAP measurements.
COMPLETED
NA
214 participants
MAP measurements were recorded every 20 s by the EV1000 system from induction (start anesthesia) to leaving Operation room (end of surgery).
2021-05-19
Participant Flow
214 met inclusion criteria and were randomized to treatment. One patient was excluded from analysis due to non-availability of data from technical issues.
Participant milestones
| Measure |
Arterial Line - Control
Arterial line waveform and pressure
Control: Arterial waveform and pressures
|
Acumen HPI-enabled EV1000 Screen
Arterial line waveform and pressure + HPI alert from EV1000 monitor
Acumen HPI-enabled EV1000 screen: Acumen HPI-enabled EV1000 screen.
|
|---|---|---|
|
Overall Study
STARTED
|
108
|
106
|
|
Overall Study
COMPLETED
|
108
|
105
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Arterial Line - Control
Arterial line waveform and pressure
Control: Arterial waveform and pressures
|
Acumen HPI-enabled EV1000 Screen
Arterial line waveform and pressure + HPI alert from EV1000 monitor
Acumen HPI-enabled EV1000 screen: Acumen HPI-enabled EV1000 screen.
|
|---|---|---|
|
Overall Study
Device didn't work
|
0
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Arterial Line - Control
n=108 Participants
Arterial line waveform and pressure
Control: Arterial waveform and pressures
|
Acumen HPI-enabled EV1000 Screen
n=105 Participants
Arterial line waveform and pressure + HPI alert from EV1000 monitor
Acumen HPI-enabled EV1000 screen: Acumen HPI-enabled EV1000 screen.
|
Total
n=213 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66 years
STANDARD_DEVIATION 10 • n=108 Participants
|
67 years
STANDARD_DEVIATION 10 • n=105 Participants
|
66 years
STANDARD_DEVIATION 10 • n=213 Participants
|
|
Sex: Female, Male
Female
|
43 Participants
n=108 Participants
|
47 Participants
n=105 Participants
|
90 Participants
n=213 Participants
|
|
Sex: Female, Male
Male
|
65 Participants
n=108 Participants
|
58 Participants
n=105 Participants
|
123 Participants
n=213 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: MAP measurements were recorded every 20 s by the EV1000 system from induction (start anesthesia) to leaving Operation room (end of surgery).MAP stands for mean arterial pressure. Time-weighted average MAP below 65 mmHg threshold for each patient was derived by dividing AUC-MAP by the time interval between the first and the last MAP measurements.
Outcome measures
| Measure |
Arterial Line - Control
n=108 Participants
Arterial line waveform and pressure
Control: Arterial waveform and pressures
|
Acumen HPI-enabled EV1000 Screen
n=105 Participants
Arterial line waveform and pressure + HPI alert from EV1000 monitor
Acumen HPI-enabled EV1000 screen: Acumen HPI-enabled EV1000 screen.
|
|---|---|---|
|
Time- Weighted Average (TWA) MAP Under a Threshold of 65 mmHg.
|
0.14 mmHg
Interval 0.03 to 0.39
|
0.14 mmHg
Interval 0.03 to 0.37
|
PRIMARY outcome
Timeframe: MAP measurements were recorded every 20 s by the EV1000 system from induction (start anesthesia) to leaving Operation room (end of surgery) .MAP stands for mean arterial pressure; Calculation of a specific area started when MAP was less than 65 mmHg and ended when MAP was greater than 65 mmHg; Hypotension severity (AUC-MAP) below the threshold of 65 mmHg was calculated as the cumulative sum of the areas below the given threshold for a patient using the trapezoid rule and measured in units of mmHg times minutes.
Outcome measures
| Measure |
Arterial Line - Control
n=108 Participants
Arterial line waveform and pressure
Control: Arterial waveform and pressures
|
Acumen HPI-enabled EV1000 Screen
n=105 Participants
Arterial line waveform and pressure + HPI alert from EV1000 monitor
Acumen HPI-enabled EV1000 screen: Acumen HPI-enabled EV1000 screen.
|
|---|---|---|
|
Hypotension Severity (AUC-MAP) Under a Threshold of 65.
|
34.2 mmHg·min
Interval 8.5 to 112.7
|
32.7 mmHg·min
Interval 6.3 to 102.0
|
PRIMARY outcome
Timeframe: MAP measurements were recorded every 20 s by the EV1000 system from induction (start anesthesia) to leaving Operation room (end of surgery).MAP stands for mean arterial pressure; Duration is the total amount of time (in minutes) that the MAP under a threshold of 65 mmHg
Outcome measures
| Measure |
Arterial Line - Control
n=108 Participants
Arterial line waveform and pressure
Control: Arterial waveform and pressures
|
Acumen HPI-enabled EV1000 Screen
n=105 Participants
Arterial line waveform and pressure + HPI alert from EV1000 monitor
Acumen HPI-enabled EV1000 screen: Acumen HPI-enabled EV1000 screen.
|
|---|---|---|
|
Duration of MAP Under a Threshold of 65 mmHg.
|
9.3 min
Interval 2.3 to 23.5
|
7.7 min
Interval 2.0 to 18.3
|
SECONDARY outcome
Timeframe: MAP measurements were recorded every 20 s by the EV1000 system from induction (start anesthesia) to leaving Operation room (end of surgery).MAP stands for mean arterial pressure. Time-weighted average MAP below 60 mmHg threshold for each patient was derived by dividing AUC-MAP by the time interval between the first and the last MAP measurements.
Outcome measures
| Measure |
Arterial Line - Control
n=108 Participants
Arterial line waveform and pressure
Control: Arterial waveform and pressures
|
Acumen HPI-enabled EV1000 Screen
n=105 Participants
Arterial line waveform and pressure + HPI alert from EV1000 monitor
Acumen HPI-enabled EV1000 screen: Acumen HPI-enabled EV1000 screen.
|
|---|---|---|
|
Time-weighted Average MAP Below a Threshold of 60 mmHg Per Case
|
0.02 mmHg
Interval 0.0 to 0.11
|
0.03 mmHg
Interval 0.0 to 0.13
|
SECONDARY outcome
Timeframe: MAP measurements were recorded every 20 s by the EV1000 system from induction (start anesthesia) to leaving Operation room (end of surgery).MAP stands for mean arterial pressure. Time-weighted average MAP below 55 mmHg threshold for each patient was derived by dividing AUC-MAP by the time interval between the first and the last MAP measurements.
Outcome measures
| Measure |
Arterial Line - Control
n=108 Participants
Arterial line waveform and pressure
Control: Arterial waveform and pressures
|
Acumen HPI-enabled EV1000 Screen
n=105 Participants
Arterial line waveform and pressure + HPI alert from EV1000 monitor
Acumen HPI-enabled EV1000 screen: Acumen HPI-enabled EV1000 screen.
|
|---|---|---|
|
Time-weighted Average MAP Below a Threshold of 55 mmHg Per Case
|
0 mmHg
Interval 0.0 to 0.03
|
0 mmHg
Interval 0.0 to 0.04
|
SECONDARY outcome
Timeframe: MAP measurements were recorded every 20 s by the EV1000 system from induction (start anesthesia) to leaving Operation room (end of surgery).MAP stands for mean arterial pressure; Calculation of a specific area started when MAP was less than 60 mmHg and ended when MAP was greater than 60 mmHg. Hypotension severity (AUC-MAP) below the threshold of 60 mmHg was calculated as the cumulative sum of the areas below the given threshold for a patient using the trapezoid rule and measured in units of mmHg times minutes.
Outcome measures
| Measure |
Arterial Line - Control
n=108 Participants
Arterial line waveform and pressure
Control: Arterial waveform and pressures
|
Acumen HPI-enabled EV1000 Screen
n=105 Participants
Arterial line waveform and pressure + HPI alert from EV1000 monitor
Acumen HPI-enabled EV1000 screen: Acumen HPI-enabled EV1000 screen.
|
|---|---|---|
|
Hypotension Severity (AUC-MAP) Under a Threshold of 60 mmHg.
|
5.3 mmHg·min
Interval 0.0 to 29.2
|
6.0 mmHg·min
Interval 0.33 to 28.3
|
SECONDARY outcome
Timeframe: MAP measurements were recorded every 20 s by the EV1000 system from induction (start anesthesia) to leaving Operation room (end of surgery).MAP stands for mean arterial pressure; Calculation of a specific area started when MAP was less than 55 mmHg and ended when MAP was greater than 55 mmHg. Hypotension severity (AUC-MAP) below the threshold of 55 mmHg was calculated as the cumulative sum of the areas below the given threshold for a patient using the trapezoid rule and measured in units of mmHg times minutes.
Outcome measures
| Measure |
Arterial Line - Control
n=108 Participants
Arterial line waveform and pressure
Control: Arterial waveform and pressures
|
Acumen HPI-enabled EV1000 Screen
n=105 Participants
Arterial line waveform and pressure + HPI alert from EV1000 monitor
Acumen HPI-enabled EV1000 screen: Acumen HPI-enabled EV1000 screen.
|
|---|---|---|
|
Hypotension Severity (AUC-MAP) Under a Threshold of 55 mmHg.
|
0.17 mmHg·min
Interval 0.0 to 6.7
|
1.00 mmHg·min
Interval 0.0 to 7.7
|
SECONDARY outcome
Timeframe: MAP measurements were recorded every 20 s by the EV1000 system from induction (start anesthesia) to leaving Operation room (end of surgery).MAP stands for mean arterial pressure; Duration is the total amount of time (in minutes) that the MAP under a threshold of 60 mmHg
Outcome measures
| Measure |
Arterial Line - Control
n=108 Participants
Arterial line waveform and pressure
Control: Arterial waveform and pressures
|
Acumen HPI-enabled EV1000 Screen
n=105 Participants
Arterial line waveform and pressure + HPI alert from EV1000 monitor
Acumen HPI-enabled EV1000 screen: Acumen HPI-enabled EV1000 screen.
|
|---|---|---|
|
Duration of MAP Under a Threshold of 60 mmHg.
|
2.0 min
Interval 0.0 to 7.7
|
2.0 min
Interval 0.33 to 7.3
|
SECONDARY outcome
Timeframe: MAP measurements were recorded every 20 s by the EV1000 system from induction (start anesthesia) to leaving Operation room (end of surgery).MAP stands for mean arterial pressure; Duration is the total amount of time (in minutes) that the MAP under a threshold of 55 mmHg.
Outcome measures
| Measure |
Arterial Line - Control
n=108 Participants
Arterial line waveform and pressure
Control: Arterial waveform and pressures
|
Acumen HPI-enabled EV1000 Screen
n=105 Participants
Arterial line waveform and pressure + HPI alert from EV1000 monitor
Acumen HPI-enabled EV1000 screen: Acumen HPI-enabled EV1000 screen.
|
|---|---|---|
|
Duration of MAP Under a Threshold of 55 mmHg.
|
0.17 min
Interval 0.0 to 1.7
|
0.67 min
Interval 0.0 to 2.3
|
Adverse Events
Arterial Line - Control
Acumen HPI-enabled EV1000 Screen
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place