Trial Outcomes & Findings for Measurement of NonInvasive Blood Pressure in Neonates Through Adults and Special Populations (NCT NCT02125331)

Results Overview

Comparison of the following measurements: non-invasive blood pressure to invasive blood pressure. This is done with a beat to beat comparison. Each pulse from the analyzed time interval (non-invasive blood pressure determination) provides a systolic, MAP and diastolic value and that is compared to the waveform collected at the same timepoint for the invasive BP (measurement). Criteria is defined in ANSI/AAMI/ISO 81060-2 NIBP Standard. Mean \& SD of the IBP derived from the IBP wave recordings during a NIBP determination will be calculated; and the range of reference IBP will be determined as mean ±1 standard deviation (SD) of the IBPs. The same method will be used for both systolic and diastolic blood pressures. Data may be excluded for analysis when the range of invasive systolic BP is wider than 20 mmHg or when the range of invasive diastolic BP is wider than 12 mmHg, as such that analysis is performed in accordance with ISO 81060-2:2013.

Recruitment status

TERMINATED

Target enrollment

83 participants

Primary outcome timeframe

60 minutes

Results posted on

2020-06-11

Participant Flow

Participant milestones

Participant milestones
Measure	PDM-SuperSTAT PDM-SuperSTAT Arm (minimum of 55 evaluable patients): GE DINAMAP® SuperSTAT algorithm delivered by the PDM acquisition module connected to the CARESCAPE Monitor B650 Device: Blood pressure monitoring with GE Healthcare CARESCAPE B650 Patient Monitor-Patient Side Module (PSM) or Patient Data Module (PDM): 3-15 Non-Invasive Blood Pressure readings on the CARESCAPE B650 Patient Monitor equipped with PSM-Datex-Ohmeda and PDM-SuperSTAT NIBP measurement devices during non-emergent heart catheterization	PSM-Datex-Ohmeda PSM-Datex-Ohmeda Arm (minimum of 45 evaluable patients): Datex-Ohmeda delivered by the PSM acquisition module connected to the CARESCAPE Monitor B650 Device: Blood pressure monitoring with GE Healthcare CARESCAPE B650 Patient Monitor-Patient Side Module (PSM) or Patient Data Module (PDM): 3-15 Non-Invasive Blood Pressure readings on the CARESCAPE B650 Patient Monitor equipped with PSM-Datex-Ohmeda and PDM-SuperSTAT NIBP measurement devices during non-emergent heart catheterization
Overall Study STARTED	58	25
Overall Study COMPLETED	53	25
Overall Study NOT COMPLETED	5	0

Reasons for withdrawal

Reasons for withdrawal
Measure	PDM-SuperSTAT PDM-SuperSTAT Arm (minimum of 55 evaluable patients): GE DINAMAP® SuperSTAT algorithm delivered by the PDM acquisition module connected to the CARESCAPE Monitor B650 Device: Blood pressure monitoring with GE Healthcare CARESCAPE B650 Patient Monitor-Patient Side Module (PSM) or Patient Data Module (PDM): 3-15 Non-Invasive Blood Pressure readings on the CARESCAPE B650 Patient Monitor equipped with PSM-Datex-Ohmeda and PDM-SuperSTAT NIBP measurement devices during non-emergent heart catheterization	PSM-Datex-Ohmeda PSM-Datex-Ohmeda Arm (minimum of 45 evaluable patients): Datex-Ohmeda delivered by the PSM acquisition module connected to the CARESCAPE Monitor B650 Device: Blood pressure monitoring with GE Healthcare CARESCAPE B650 Patient Monitor-Patient Side Module (PSM) or Patient Data Module (PDM): 3-15 Non-Invasive Blood Pressure readings on the CARESCAPE B650 Patient Monitor equipped with PSM-Datex-Ohmeda and PDM-SuperSTAT NIBP measurement devices during non-emergent heart catheterization
Overall Study Protocol Violation	1	0
Overall Study technical problem	2	0
Overall Study screen failure	2	0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PDM-SuperSTAT n=58 Participants PDM-SuperSTAT Arm (minimum of 55 evaluable patients): GE DINAMAP® SuperSTAT algorithm delivered by the PDM acquisition module connected to the CARESCAPE Monitor B650 Device: Blood pressure monitoring with GE Healthcare CARESCAPE B650 Patient Monitor-Patient Side Module (PSM) or Patient Data Module (PDM): 3-15 Non-Invasive Blood Pressure readings on the CARESCAPE B650 Patient Monitor equipped with PSM-Datex-Ohmeda and PDM-SuperSTAT NIBP measurement devices during non-emergent heart catheterization	PSM-Datex-Ohmeda n=25 Participants PSM-Datex-Ohmeda Arm (minimum of 45 evaluable patients): Datex-Ohmeda delivered by the PSM acquisition module connected to the CARESCAPE Monitor B650 Device: Blood pressure monitoring with GE Healthcare CARESCAPE B650 Patient Monitor-Patient Side Module (PSM) or Patient Data Module (PDM): 3-15 Non-Invasive Blood Pressure readings on the CARESCAPE B650 Patient Monitor equipped with PSM-Datex-Ohmeda and PDM-SuperSTAT NIBP measurement devices during non-emergent heart catheterization	Total n=83 Participants Total of all reporting groups
Age, Customized Subjects >= 3 years	34 Participants n=58 Participants	19 Participants n=25 Participants	53 Participants n=83 Participants
Age, Customized Subjects < 3 years	24 Participants n=58 Participants	6 Participants n=25 Participants	30 Participants n=83 Participants
Sex: Female, Male Female	25 Participants n=58 Participants	13 Participants n=25 Participants	38 Participants n=83 Participants
Sex: Female, Male Male	33 Participants n=58 Participants	12 Participants n=25 Participants	45 Participants n=83 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Subjects with Chronic Atrial Fibrillation	2 Participants n=58 Participants	0 Participants n=25 Participants	2 Participants n=83 Participants

PRIMARY outcome

Timeframe: 60 minutes

Population: The PDM-SuperSTAT arm was analyzed according to the ISO 81060-2:2013(E) standard. As the PSM-Datex-Ohmeda was prematurely terminated, PASS/FAIL criteria were unable to be determined.

Comparison of the following measurements: non-invasive blood pressure to invasive blood pressure. This is done with a beat to beat comparison. Each pulse from the analyzed time interval (non-invasive blood pressure determination) provides a systolic, MAP and diastolic value and that is compared to the waveform collected at the same timepoint for the invasive BP (measurement). Criteria is defined in ANSI/AAMI/ISO 81060-2 NIBP Standard. Mean \& SD of the IBP derived from the IBP wave recordings during a NIBP determination will be calculated; and the range of reference IBP will be determined as mean ±1 standard deviation (SD) of the IBPs. The same method will be used for both systolic and diastolic blood pressures. Data may be excluded for analysis when the range of invasive systolic BP is wider than 20 mmHg or when the range of invasive diastolic BP is wider than 12 mmHg, as such that analysis is performed in accordance with ISO 81060-2:2013.

Outcome measures

Outcome measures
Measure	PDM-SuperSTAT n=53 Participants PDM-SuperSTAT Arm (minimum of 55 evaluable patients): GE DINAMAP® SuperSTAT algorithm delivered by the PDM acquisition module connected to the CARESCAPE Monitor B650 The result of the analysis of mean blood pressure measurement errors shows the PDM-SuperSTAT arm population groups ≥ 3 years old and \< 3 years old passed the acceptance criteria. However, the Chronic AFib subgroup population of ≥ 3- years old did not meet the subject enrollment because of the challenging population; but as a group, the NIBP determinations for the PDM-SuperSTAT arm for both population group of ≥ 3 years old and \< 3 years old showed the study conformed to ISO 81060-2:2013(E) standards.	PSM-Datex-Ohmeda n=25 Participants PSM-Datex-Ohmeda Arm (minimum of 45 evaluable patients): Datex-Ohmeda delivered by the PSM acquisition module connected to the CARESCAPE Monitor B650 For the PSM-Datex-Ohmeda arm population group ≥ 3 years old and \< 3 years old that was prematurely terminated as a result of the business decision that the data was no longer needed to satisfy the business requirements, as a whole, did not meet the ISO 81060-2:2013(E) standards; therefore, PASS/FAIL criteria were unable to be determined.
Number of Participants With Accurate NIBP Measurements as Confirmed by IBP Measurements	40 Participants	19 Participants

Adverse Events

PDM-SuperSTAT

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

PSM-Datex-Ohmeda

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	PDM-SuperSTAT n=58 participants at risk PDM-SuperSTAT Arm (minimum of 55 evaluable patients): GE DINAMAP® SuperSTAT algorithm delivered by the PDM acquisition module connected to the CARESCAPE Monitor B650 Device: Blood pressure monitoring with GE Healthcare CARESCAPE B650 Patient Monitor-Patient Side Module (PSM) or Patient Data Module (PDM): 3-15 Non-Invasive Blood Pressure readings on the CARESCAPE B650 Patient Monitor equipped with PSM-Datex-Ohmeda and PDM-SuperSTAT NIBP measurement devices during non-emergent heart catheterization	PSM-Datex-Ohmeda n=25 participants at risk PSM-Datex-Ohmeda Arm (minimum of 45 evaluable patients): Datex-Ohmeda delivered by the PSM acquisition module connected to the CARESCAPE Monitor B650 Device: Blood pressure monitoring with GE Healthcare CARESCAPE B650 Patient Monitor-Patient Side Module (PSM) or Patient Data Module (PDM): 3-15 Non-Invasive Blood Pressure readings on the CARESCAPE B650 Patient Monitor equipped with PSM-Datex-Ohmeda and PDM-SuperSTAT NIBP measurement devices during non-emergent heart catheterization
Injury, poisoning and procedural complications Cuff irritation	3.4% 2/58 • Number of events 2 • The duration over which adverse events were monitored/assessed was 2 hours.	0.00% 0/25 • The duration over which adverse events were monitored/assessed was 2 hours.
Surgical and medical procedures Heart Block	1.7% 1/58 • Number of events 1 • The duration over which adverse events were monitored/assessed was 2 hours.	0.00% 0/25 • The duration over which adverse events were monitored/assessed was 2 hours.

Additional Information

Clinical Affairs Project Manager

GE Healthcare

Phone: 262-443-7008

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee All proposed publications using study data, in full or in part, will be subject to approval by the Sponsor prior to submission. The Investigator and Sponsor agree to act in good faith to consider the interests of each party in publication.
Publication restrictions are in place

Restriction type: OTHER