Trial Outcomes & Findings for Clinical Performance of Masimo INVSENSOR00040 (NCT NCT05332392)

Last Updated: 2024-06-11

Results Overview

SpO2 performance will be determined by calculating the arithmetic root square mean (ARMS) value through the comparison of the noninvasive SpO2 measurement obtained from INVSENSOR00040 to the arterial oxygen saturation (SaO2) value obtained from a reference blood sample. The square root of the sum of the squares of bias and precision is computed as the ARMS Error Value. The desaturation range over which the accuracy is performed is 70-100%.

Recruitment status

COMPLETED

Study phase

Target enrollment

90 participants

Primary outcome timeframe

1-5 hours

Results posted on

2024-06-11

Participant Flow

Participant milestones

Participant milestones
Measure	INVSENSOR00040 All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00040 device. INVSENSOR00040: Noninvasive wearable health monitoring device
Overall Study STARTED	90
Overall Study COMPLETED	46
Overall Study NOT COMPLETED	44

Reasons for withdrawal

Reasons for withdrawal
Measure	INVSENSOR00040 All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00040 device. INVSENSOR00040: Noninvasive wearable health monitoring device
Overall Study Did not meet inclusion criteria	25
Overall Study Principal Investigator's decision	17
Overall Study Adverse Event	1
Overall Study Subject's decision	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	INVSENSOR00040 n=46 Participants All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00040 device. INVSENSOR00040: Noninvasive wearable health monitoring device
Age, Categorical <=18 years	0 Participants n=46 Participants
Age, Categorical Between 18 and 65 years	46 Participants n=46 Participants
Age, Categorical >=65 years	0 Participants n=46 Participants
Sex: Female, Male Female	17 Participants n=46 Participants
Sex: Female, Male Male	29 Participants n=46 Participants
Race/Ethnicity, Customized Ethnicity · African American	15 Participants n=46 Participants
Race/Ethnicity, Customized Ethnicity · Asian or Pacific Islander	9 Participants n=46 Participants
Race/Ethnicity, Customized Ethnicity · African American & Asian or Pacific Islander	1 Participants n=46 Participants
Race/Ethnicity, Customized Ethnicity · Hispanic	9 Participants n=46 Participants
Race/Ethnicity, Customized Ethnicity · White	11 Participants n=46 Participants
Race/Ethnicity, Customized Ethnicity · White & Native American	1 Participants n=46 Participants
Region of Enrollment United States	46 participants n=46 Participants

PRIMARY outcome

Timeframe: 1-5 hours

Population: Data from 13 subjects was excluded due to desaturation procedural error. Data from 1 subject was excluded due to missing data and evidence of noise interference that did not allow for the comparison of the dataset. Data from 1 subject was excluded because the subject complained of discomfort at the early part of the desaturation procedure and therefore was unable to desaturate to below 90% SaO2.

Outcome measures

Outcome measures
Measure	INVSENSOR00040 n=31 Participants All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00040 device. INVSENSOR00040: Noninvasive wearable health monitoring device
Oxygen Saturation (SpO2) Accuracy of INVSENSOR00040	1.62 % of oxygen saturated hemoglobin

PRIMARY outcome

Timeframe: 1-5 hours

Population: Data from 13 subjects excluded due to desaturation procedural error. Data from 1 subject excluded due to missing data \& evidence of noise interference that did not allow for the comparison of the dataset. Data from 1 subject excluded because subject complained of discomfort at early part of desaturation procedure, therefore was unable to desaturate to below 90% SaO2. Data from 2 subjects excluded for no valid PR \& ECG HR pair, because ECG HR data was not recorded in the server properly.

Pulse Rate (PR) performance will be determined by calculating the ARMS value through the comparison of the PR values obtained from INVSENSOR00040 to the heart rate (HR) values obtained from a reference standard of care EKG monitor. The square root of the sum of the squares of bias and precision is computed as the ARMS Error Value. The PR/HR range over which the accuracy is calculated is determined by convenience sampling in a generally healthy population undergoing a desaturation procedure.

Outcome measures

Outcome measures
Measure	INVSENSOR00040 n=29 Participants All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00040 device. INVSENSOR00040: Noninvasive wearable health monitoring device
Pulse Rate (PR) Accuracy of INVSENSOR00040	1.29 beats per minute

Adverse Events

INVSENSOR00040

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	INVSENSOR00040 n=46 participants at risk All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00040 device. INVSENSOR00040: Noninvasive wearable health monitoring device
Injury, poisoning and procedural complications Unilateral temporal headache	2.2% 1/46 • Number of events 1 • 1 to 5 hours
Injury, poisoning and procedural complications Lightheadedness	2.2% 1/46 • Number of events 1 • 1 to 5 hours
Injury, poisoning and procedural complications Swelling/Tenderness at arterial line site	4.3% 2/46 • Number of events 2 • 1 to 5 hours

Additional Information

Ahmed Alghazi

Masimo

Phone: 949-297-7437

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place