Trial Outcomes & Findings for Desaturation Validation of INVSENSOR00036 (NCT NCT04002960)

NCT ID: NCT04002960

Last Updated: 2020-10-20

Results Overview

This study will evaluate the trending accuracy of the INVSENSOR00036 relative to the reference value obtained from the comparative FDA-cleared device.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 23 participants
• Primary outcome timeframe: 1-5 hours
• Results posted on: 2020-10-20

Participant Flow

Participant milestones

Measure	INVSENSOR00036 All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00036 sensor.
Overall Study STARTED	23
Overall Study COMPLETED	21
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure	INVSENSOR00036 All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00036 sensor.
Overall Study Withdrawn prior to Completion	2

Baseline Characteristics

Desaturation Validation of INVSENSOR00036

Baseline characteristics by cohort

Measure	INVSENSOR00036 n=21 Participants All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00036 sensor.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	21 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	6 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	6 Participants n=5 Participants
Race/Ethnicity, Customized Asian or Pacific Islander	3 Participants n=5 Participants
Race/Ethnicity, Customized Native American	0 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	6 Participants n=5 Participants
Race/Ethnicity, Customized Other	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1-5 hours

This study will evaluate the trending accuracy of the INVSENSOR00036 relative to the reference value obtained from the comparative FDA-cleared device.

Outcome measures

Measure	INVSENSOR00036 n=21 Participants All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00036 sensor.
Trending Accuracy of INVSENSOR00036	1.8 percentage of regional oxygen saturation

Adverse Events

INVSENSOR00036

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	INVSENSOR00036 n=23 participants at risk All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00036 sensor.
Injury, poisoning and procedural complications Chest tightness	4.3% 1/23 • 1 to 5 hours

Additional Information

Chelsea Frank

Masimo

Phone: 949-297-7000

Email: studies@masimo.com

Results disclosure agreements

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