Trial Outcomes & Findings for Comparison of Non-invasive and Invasive Blood Pressure Monitors (NCT NCT04506775)

Results Overview

255 time points compared across continuous blood pressure (mmHg) As per the FDA standard ANSI/AAMI SP10:2008 or the newly adopted ISO 81060-3:2022 standard, the mean error should be \<5mmHg or \<6mmHg and the standard deviation should be \<8mmHg or \<10mmHg respectively.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

30 participants

Primary outcome timeframe

Up to 24 Hours

Results posted on

2025-09-10

Participant Flow

Unit of analysis: Wrist

Participant milestones

Participant milestones
Measure	All Study Participants Wrist one will have the ViTrack wrist cuff on one wrist. ViTrack: ViTrack is a continuous non-invasive wearable blood pressure cuff. Wrist two with the radial artery catheter in the opposite wrist. Radial artery catheterization: Radial artery catheterization is the standard of care for measuring blood pressure continuously throughout surgery.
Overall Study STARTED	30 30
Overall Study Wrist 1 (Control)	30 30
Overall Study Wrist 2 (ViTrack)	30 30
Overall Study COMPLETED	30 30
Overall Study NOT COMPLETED	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Participants n=30 Participants Wrist one will have both the ViTrack wrist cuff on one wrist. ViTrack: ViTrack is a continuous non-invasive wearable blood pressure cuff. Wrist two and the radial artery catheter in the opposite wrist. Radial artery catheterization: Radial artery catheterization is the standard of care for measuring blood pressure continuously throughout surgery.
Age, Categorical <=18 years	0 Participants n=30 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=30 Participants
Age, Categorical >=65 years	21 Participants n=30 Participants
Age, Continuous	69.4 Years n=30 Participants
Sex: Female, Male Female	8 Participants n=30 Participants
Sex: Female, Male Male	22 Participants n=30 Participants
Region of Enrollment United States	30 participants n=30 Participants

PRIMARY outcome

Timeframe: Up to 24 Hours

Population: Wrist 1, the ViTrack wrist cuff represents the experimental arm of the study. Wrist 2, the radial arterial catheter, represents the gold standard arterial blood pressure monitor that the ViTrack device is being compared to. The outcome DBP for the ViTrack device reports the mean error and standard deviation for the ViTrack device in comparison to the gold standard in alignment with the FDA standards.

255 time points compared across continuous blood pressure (mmHg) As per the FDA standard ANSI/AAMI SP10:2008 or the newly adopted ISO 81060-3:2022 standard, the mean error should be \<5mmHg or \<6mmHg and the standard deviation should be \<8mmHg or \<10mmHg respectively.

Outcome measures

Outcome measures
Measure	All Study Participants n=30 Participants Wrist one will have both the ViTrack wrist cuff on one wrist. ViTrack: ViTrack is a continuous non-invasive wearable blood pressure cuff. Wrist two and the radial artery catheter in the opposite wrist. Radial artery catheterization: Radial artery catheterization is the standard of care for measuring blood pressure continuously throughout surgery.
Comparison of Diastolic Blood Pressure	0.90 mmHg Standard Deviation 5.97

PRIMARY outcome

Timeframe: Up to 24 Hours

Population: Wrist 1, the ViTrack wrist cuff represents the experimental arm of the study. Wrist 2, the radial arterial catheter, represents the gold standard arterial blood pressure monitor that the ViTrack device is being compared to. The outcome SBP for the ViTrack device reports the mean error and standard deviation for the ViTrack device in comparison to the gold standard in alignment with the FDA standards.

255 time points compared across continuous blood pressure (mmHg) As per the FDA standard ANSI/AAMI SP10:2008 or the newly adopted ISO 81060-3:2022 standard, the mean error should be \<5mmHg or \<6mmHg and the standard deviation should be \<8mmHg or \<10mmHg respectively.

Outcome measures

Outcome measures
Measure	All Study Participants n=30 Participants Wrist one will have both the ViTrack wrist cuff on one wrist. ViTrack: ViTrack is a continuous non-invasive wearable blood pressure cuff. Wrist two and the radial artery catheter in the opposite wrist. Radial artery catheterization: Radial artery catheterization is the standard of care for measuring blood pressure continuously throughout surgery.
Comparison of Systolic Blood Pressure	0.19 mmHg Standard Deviation 5.70

SECONDARY outcome

Timeframe: Up to 72 hours

Examining for local skin irritation

Outcome measures

Outcome measures
Measure	All Study Participants n=30 Participants Wrist one will have both the ViTrack wrist cuff on one wrist. ViTrack: ViTrack is a continuous non-invasive wearable blood pressure cuff. Wrist two and the radial artery catheter in the opposite wrist. Radial artery catheterization: Radial artery catheterization is the standard of care for measuring blood pressure continuously throughout surgery.
Skin Irritation	0 Participants

Adverse Events

All Study Participants

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

J. Aaron Scott, DO

UMass Chan Medical School

Phone: 774-303-4156

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place