Trial Outcomes & Findings for Validation of a Vital Signs Monitoring Wristband (NCT NCT05566886)

Results Overview

Root-mean-squared error between PPG measured and gold standard measured heart rate

Recruitment status

COMPLETED

Target enrollment

100 participants

Primary outcome timeframe

30 minutes

Results posted on

2025-05-04

Participant Flow

124 subjects undergoing heart catheterization were screened. 24 participants were not included due to: * Lateral difference exceeding limits (n=8) * Arm circumference not within range (n=1) * Atrial fibrillation or arrhythmia (n=5) * Peripheral artery disease (n=3) * Unforeseen difficulties during procedure (n=2) * Other medical reasons (e.g., isolation for infection) (n=1) * Technical difficulties (measurement not started) (n=1) * Procedure canceled or postponed (n=3)

Participant milestones

Participant milestones
Measure	Main Study Group Subjects undergoing heart catheterization as standard of care.
Overall Study STARTED	100
Overall Study COMPLETED	100
Overall Study NOT COMPLETED	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	Main Study Group n=100 Participants Subjects undergoing heart catheterization as standard of care.
Age, Continuous	67.4 years STANDARD_DEVIATION 11.1 • n=100 Participants
Sex: Female, Male Female	33 Participants n=100 Participants
Sex: Female, Male Male	67 Participants n=100 Participants
Skin colour (Fitzpatrick) Fitzpatrick Class I-II	81 Participants n=100 Participants
Skin colour (Fitzpatrick) Fitzpatrick Class III-IV	16 Participants n=100 Participants
Skin colour (Fitzpatrick) Fitzpatrick Class V-VI	3 Participants n=100 Participants

PRIMARY outcome

Timeframe: 30 minutes

Root-mean-squared error between PPG measured and gold standard measured heart rate

Outcome measures

Outcome measures
Measure	Main Study Group n=945 epochs (28 second) Subjects undergoing heart catheterization as standard of care.
RMSE of Heart Rate	1.3 beats per minute Interval -5.5 to 4.2

PRIMARY outcome

Timeframe: 30 minutes

Root-mean-squared error between PPG measured and gold standard measured respiratory rate

Outcome measures

Outcome measures
Measure	Main Study Group n=945 epochs (28 second) Subjects undergoing heart catheterization as standard of care.
RMSE of Respiratory Rate	0.9 breaths per minute Interval -2.1 to 2.0

PRIMARY outcome

Timeframe: 30 minutes

Root-mean-squared error between PPG measured and gold standard measured oxygen saturation

Outcome measures

Outcome measures
Measure	Main Study Group n=945 epochs (28 second) Subjects undergoing heart catheterization as standard of care.
RMSE of Oxygen Saturation	1.6 % of SpO2 Interval -3.2 to 3.9

PRIMARY outcome

Timeframe: 30 minutes

Population: 100 subjects were included, however, 3 individuals did not meet pre-specified dampening criteria As a result data of 97 patients and 420 measurement pairs was included in the analysis.

Root-mean-squared error between PPG measured and gold standard measured blood pressure (systolic blood pressure and diastolic blood pressure)

Outcome measures

Outcome measures
Measure	Main Study Group n=420 paired samples Subjects undergoing heart catheterization as standard of care.
RMSE of Blood Pressure Systolic Blood Pressure	3.7 mmHg Standard Deviation 4.4
RMSE of Blood Pressure Diastolic Blood Pressure	2.5 mmHg Standard Deviation 3.7

Adverse Events

Main Study Group

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

Clinical Research Manager

Corsano Health B.V.

Phone: +31 61 640 7778

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place