Trial Outcomes & Findings for Accuracy of Non-invasive Non-oscillometric Blood Pressure Wristband (NCT NCT03629535)

NCT ID: NCT03629535

Last Updated: 2021-02-02

Results Overview

If the value obtained from the LiveMetric determination lied within the range of the reference BP, an error of 0 mm Hg (0kPa) was assigned to this determination. If the value obtained from the LiveMetric determination lies outside the range of the reference BP, the value of the determination from the adjacent limit of the range of the variation of BP was subtracted. That difference represents the error for this determination. The arithmetic mean of the error is calculated and its experimental standard deviation from the errors of each recording for each BP value (Systolic \& Diastolic) and determination for each patient.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 8 participants
• Primary outcome timeframe: during intervention for 30 minutes
• Results posted on: 2021-02-02

Participant Flow

Participant milestones

Measure	Patients in SICU Patients in the SICU with an intra-arterial blood pressure monitor already in place will be considered as subjects. Non-invasive non-oscillometric blood pressure wristband device: The device is a band intended to be worn on the wrist for intermittent blood pressure measurements. The device applies no inflatable mechanics or moving parts. The wristband is watertight and can be worn as any type of bracelet. Invasive intra-arterial blood pressure monitors.: Because the subjects also have an intra-arterial blood pressure monitor in place, the subjects will serve as their own control
Overall Study STARTED	8
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Accuracy of Non-invasive Non-oscillometric Blood Pressure Wristband

Baseline characteristics by cohort

Measure	Patients in SICU n=8 Participants Patients in the SICU with an intra-arterial blood pressure monitor already in place will be considered as subjects. Non-invasive non-oscillometric blood pressure wristband device: The device is a band intended to be worn on the wrist for intermittent blood pressure measurements. The device applies no inflatable mechanics or moving parts. The wristband is watertight and can be worn as any type of bracelet. Invasive intra-arterial blood pressure monitors.: Because the subjects also have an intra-arterial blood pressure monitor in place, the subjects will serve as their own control
Age, Continuous	61.6 years STANDARD_DEVIATION 16.4 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 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	3 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants
Region of Enrollment United States	8 participants n=5 Participants

PRIMARY outcome

Timeframe: during intervention for 30 minutes

If the value obtained from the LiveMetric determination lied within the range of the reference BP, an error of 0 mm Hg (0kPa) was assigned to this determination. If the value obtained from the LiveMetric determination lies outside the range of the reference BP, the value of the determination from the adjacent limit of the range of the variation of BP was subtracted. That difference represents the error for this determination.

The arithmetic mean of the error is calculated and its experimental standard deviation from the errors of each recording for each BP value (Systolic & Diastolic) and determination for each patient.

Outcome measures

Measure	Patients in SICU n=8 Participants Patients in the SICU with an intra-arterial blood pressure monitor already in place will be considered as subjects. Non-invasive non-oscillometric blood pressure wristband device: The device is a band intended to be worn on the wrist for intermittent blood pressure measurements. The device applies no inflatable mechanics or moving parts. The wristband is watertight and can be worn as any type of bracelet. Invasive intra-arterial blood pressure monitors.: Because the subjects also have an intra-arterial blood pressure monitor in place, the subjects will serve as their own control
Average Error in Blood Pressure Readings Systolic	-1.5 mmHg Standard Deviation 6.3
Average Error in Blood Pressure Readings Diastolic	3.2 mmHg Standard Deviation 6.0

Adverse Events

Patients in SICU

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

Greta Piper, MD

NYU Langone Health

Phone: 212-263-4778

Email: Greta.Piper@nyulangone.org

Results disclosure agreements

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