Trial Outcomes & Findings for Postmarket Clinical Follow-up Study to Confirm the Performance of the Wearable Pulse-Oximeter BrOxy M (SOMBRERO) (NCT NCT04810221)

Results Overview

Accuracy of SpO2 measurements obtained with BrOxy M in comparison with the reference pulse oximeter in paired observations over a range between 80% and 100% SpO2. Based on the standard ISO 80601-2-61:2017, the accuracy is stated in terms of the root-mean-square difference between the readings of the BrOxy M and the standard readings of the reference pulse oximeter.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

19 participants

Primary outcome timeframe

The measures started around 2 minutes after beginning of the test session and ended around 33 minutes later.

Results posted on

2022-04-20

Participant Flow

A total of 19 subjects signed the informed consent and were screened for participating in the study. Of these, 3 subjects were smokers with carboxyhemoglobin (COHb) ≥ 3% and were considered screen failures. The remaining 16 were eligible and were enrolled.

Participant milestones

Participant milestones
Measure	Experimental Measure of peripheral oxygen saturation (SpO2) and heart rate (HR) obtained in enrolled subjects using BrOxy M and a reference pulse oximeter in paired observations
Overall Study STARTED	16
Overall Study COMPLETED	13
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Experimental Measure of peripheral oxygen saturation (SpO2) and heart rate (HR) obtained in enrolled subjects using BrOxy M and a reference pulse oximeter in paired observations
Overall Study Physician Decision	3

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Experimental n=12 Participants Measure of SpO2 and heart rate (HR) obtained in enrolled subjects using BrOxy M and a reference pulse oximeter in paired observations
Age, Continuous	37 years STANDARD_DEVIATION 9 • n=12 Participants
Sex: Female, Male Female	2 Participants n=12 Participants
Sex: Female, Male Male	10 Participants n=12 Participants
Skin pigmentation Skin black	4 Participants n=12 Participants
Skin pigmentation skin white	8 Participants n=12 Participants
Body/Mass Index (BMI)	26.2 kg/m^2 STANDARD_DEVIATION 3.3 • n=12 Participants

PRIMARY outcome

Timeframe: The measures started around 2 minutes after beginning of the test session and ended around 33 minutes later.

Accuracy of SpO2 measurements obtained with BrOxy M in comparison with the reference pulse oximeter in paired observations over a range between 80% and 100% SpO2. Based on the standard ISO 80601-2-61:2017, the accuracy is stated in terms of the root-mean-square difference between the readings of the BrOxy M and the standard readings of the reference pulse oximeter.

Outcome measures

Outcome measures
Measure	Experimental n=12 Participants Controlled desaturation study: Measure of SpO2 and Heart Rate by BrOxy M device and a reference device in a controlled desaturation study, in paired observations.
Accuracy of SpO2 Measurement at 80-100% SpO2	2.7 A(RMS) - % Interval -5.1 to 5.5

PRIMARY outcome

Timeframe: The test started around 2 minutes after beginning of the test session and ended after around 33 minutes.

Accuracy of measurements obtained with BrOxy M with that obtained with the reference pulse oximeter in paired observations. Based on the standard ISO 80601-2-61:2017, the accuracy is stated in terms of the root-mean-square difference between the readings of the BrOxy M and the standard readings of the reference pulse oximeter.

Outcome measures

Outcome measures
Measure	Experimental n=12 Participants Controlled desaturation study: Measure of SpO2 and Heart Rate by BrOxy M device and a reference device in a controlled desaturation study, in paired observations.
Accuracy of Heart Rate Measurement at 80-100% SpO2	3.7 bpm Interval -7.1 to 7.7

SECONDARY outcome

Timeframe: Around 5 min after beginning of the test session

Cohen's kappa coefficient to evaluate the agreement between Broxy M and the reference device for 94% SpO2 cut off. Cohen's kappa coefficient takes into account the possibility of agreement occurring by chance.

Outcome measures

Outcome measures
Measure	Experimental n=12 Participants Controlled desaturation study: Measure of SpO2 and Heart Rate by BrOxy M device and a reference device in a controlled desaturation study, in paired observations.
Agreement Between Broxy M and Reference Device SpO2 Measurements - Cut Off at 94% SpO2	0.79 Cohen's kappa coefficient

SECONDARY outcome

Timeframe: After around 10 min after beginning of the test session

Cohen's kappa coefficient to evaluate the agreement between Broxy M and the reference device for 90% SpO2 cut off

Outcome measures

Outcome measures
Measure	Experimental n=219 data pairs Controlled desaturation study: Measure of SpO2 and Heart Rate by BrOxy M device and a reference device in a controlled desaturation study, in paired observations.
Agreement Between Broxy M and the Reference Device SpO2 Measurements - Cut Off at 90% SpO2	0.80 Cohen's kappa coefficient

Adverse Events

Experimental

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

Dr. Fernando De Benedetto/President

Life Meter Srl

Phone: +39 391 4334 090

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place