Trial Outcomes & Findings for Accuracy Study of a Non-Invasive Blood Pressure Cuff in Comparison to an Invasive Radial Arterial Blood Pressure (NCT NCT01485120)

NCT ID: NCT01485120

Last Updated: 2019-05-31

Results Overview

NIBP Forearm cuff systolic and diastolic values using SuperStat algorithm compared to invasive radial blood pressure systolic and diastolic values (both obtained simultaneously).

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 34 participants
• Primary outcome timeframe: Approximately 2 hours
• Results posted on: 2019-05-31

Participant Flow

Participant milestones

Measure	Blood Pressure Monitoring Participants with blood pressure monitored using invasive and non-invasive methods. Blood pressure monitoring will take place with both devices simultaneously. The invasive "gold standard" device is a radial arterial catheter connected to the DASH 4000, while the non-invasive device is the Soft-Cuf connected to the DASH 4000 Patient Bedside Monitor with SuperSTAT NIBP software, or same with the Classic NIBP algorithm.
Overall Study STARTED	34
Overall Study COMPLETED	32
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure

Blood Pressure Monitoring Participants with blood pressure monitored using invasive and non-invasive methods. Blood pressure monitoring will take place with both devices simultaneously. The invasive "gold standard" device is a radial arterial catheter connected to the DASH 4000, while the non-invasive device is the Soft-Cuf connected to the DASH 4000 Patient Bedside Monitor with SuperSTAT NIBP software, or same with the Classic NIBP algorithm.

Overall Study Withdrawal by Subject

2

Baseline Characteristics

Accuracy Study of a Non-Invasive Blood Pressure Cuff in Comparison to an Invasive Radial Arterial Blood Pressure

Baseline characteristics by cohort

Measure	Blood Pressure Monitoring n=34 Participants Blood Pressure Monitoring using two methods: invasive radial line insertion and non-invasive blood pressure cuff
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	34 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	41.3 years STANDARD_DEVIATION 11.9 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	28 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 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	14 Participants n=5 Participants
Race (NIH/OMB) White	18 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	34 participants n=5 Participants

PRIMARY outcome

Timeframe: Approximately 2 hours

Population: Blood Pressure (BP) monitoring using invasive arterial insertion as a standard reference, and an investigational, non-invasive blood pressure (NIBP) monitoring cuff. Data obtained from the cuff used the SuperStat algorithm for output.

NIBP Forearm cuff systolic and diastolic values using SuperStat algorithm compared to invasive radial blood pressure systolic and diastolic values (both obtained simultaneously).

Outcome measures

Measure	Blood Pressure Monitoring n=32 Participants Blood Pressure (BP) monitoring using invasive arterial insertion as a standard reference, and an investigational, non-invasive blood pressure (NIBP) monitoring cuff. Data obtained from the cuff used either the SuperSTAT NIBP algorithm and the Classic NIBP algorithm for output.
Performance Comparison: NIBP Forearm Cuff Using SuperStat Algorithm vs. Invasive Radial Blood Pressure Reading Systolic value	-0.94 mmHg Standard Deviation 6.00
Performance Comparison: NIBP Forearm Cuff Using SuperStat Algorithm vs. Invasive Radial Blood Pressure Reading Diastolic value	1.39 mmHg Standard Deviation 3.69

PRIMARY outcome

Timeframe: Approximately 2 hours

Population: Blood Pressure (BP) monitoring using invasive arterial insertion as a standard reference, and an investigational, non-invasive blood pressure (NIBP) monitoring cuff. Data obtained from the cuff used the Classic NIBP algorithm for output.

NIBP Forearm cuff systolic and diastolic values using Classic algorithm difference compared to invasive radial blood pressure readings (both readings obtained simultaneously).

Outcome measures

Measure	Blood Pressure Monitoring n=32 Participants Blood Pressure (BP) monitoring using invasive arterial insertion as a standard reference, and an investigational, non-invasive blood pressure (NIBP) monitoring cuff. Data obtained from the cuff used either the SuperSTAT NIBP algorithm and the Classic NIBP algorithm for output.
Performance Comparison: NIBP Forearm Cuff Using Classic Algorithm vs. Invasive Radial Blood Pressure Reading Systolic value	0.68 mmHg Standard Deviation 7.10
Performance Comparison: NIBP Forearm Cuff Using Classic Algorithm vs. Invasive Radial Blood Pressure Reading Diastolic value	0.42 mmHg Standard Deviation 3.64

Adverse Events

Blood Pressure Monitoring

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jeff Conner

GE Healthcare

Phone: 414-721-2423

Results disclosure agreements

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