Trial Outcomes & Findings for Desaturation Validation of INVSENSOR00009 (NCT NCT03396835)

Last Updated: 2019-08-28

Results Overview

Trending ARMs accuracy is defined as root mean squared relative error of all data points of all subjects. Accuracy of the sensors will be determined by comparing regional oxygen saturation (rSO2) readings from INVSENSOR00009 and control sensor and calculating the Arithmetic root mean square (ARMS) value.

Recruitment status

COMPLETED

Study phase

Target enrollment

16 participants

Primary outcome timeframe

1-5 hours

Results posted on

2019-08-28

Participant Flow

Participant milestones

Participant milestones
Measure	INVSENSOR00009 Sensor All subjects who are enrolled into the test group and participate in data collection receive both the INVSENSOR00009 and the control sensor simultaneously on the forehead.
Overall Study STARTED	16
Overall Study COMPLETED	14
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	INVSENSOR00009 Sensor All subjects who are enrolled into the test group and participate in data collection receive both the INVSENSOR00009 and the control sensor simultaneously on the forehead.
Overall Study Withdrawn prior to completion	1
Overall Study Did not meet criteria for data analysis	1

Baseline Characteristics

One subject was withdrawn prior to completing study procedures. One subject did not meet criteria for data analysis.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	INVSENSOR00009 Sensor n=16 Participants All subjects who are enrolled into the test group and participate in data collection receive both the INVSENSOR00009 and the control sensor simultaneously on the forehead.
Age, Categorical <=18 years	0 Participants n=14 Participants • One subject was withdrawn prior to completing study procedures. One subject did not meet criteria for data analysis.
Age, Categorical Between 18 and 65 years	14 Participants n=14 Participants • One subject was withdrawn prior to completing study procedures. One subject did not meet criteria for data analysis.
Age, Categorical >=65 years	0 Participants n=14 Participants • One subject was withdrawn prior to completing study procedures. One subject did not meet criteria for data analysis.
Sex: Female, Male Female	7 Participants n=14 Participants • One subject was withdrawn prior to completing study procedures. One subject did not meet criteria for data analysis.
Sex: Female, Male Male	7 Participants n=14 Participants • One subject was withdrawn prior to completing study procedures. One subject did not meet criteria for data analysis.
Race/Ethnicity, Customized White	4 Participants n=14 Participants • One subject was withdrawn prior to completing study procedures. One subject did not meet criteria for data analysis.
Race/Ethnicity, Customized Hispanic	3 Participants n=14 Participants • One subject was withdrawn prior to completing study procedures. One subject did not meet criteria for data analysis.
Race/Ethnicity, Customized Asian or Pacific Islander	1 Participants n=14 Participants • One subject was withdrawn prior to completing study procedures. One subject did not meet criteria for data analysis.
Race/Ethnicity, Customized African American	6 Participants n=14 Participants • One subject was withdrawn prior to completing study procedures. One subject did not meet criteria for data analysis.
Region of Enrollment United States	14 Participants n=14 Participants • One subject was withdrawn prior to completing study procedures. One subject did not meet criteria for data analysis.

PRIMARY outcome

Timeframe: 1-5 hours

Outcome measures

Outcome measures
Measure	INVSENSOR00009 Sensor n=14 Participants All subjects who are enrolled into the test group and participate in data collection receive both the INVSENSOR00009 and the control sensor simultaneously on the forehead.
Trending Regional Oxygen Saturation Accuracy of the INVSENSOR00009 Relative to the Control Sensor by Arms Calculation	1.3 % tissue oxygen saturation

Adverse Events

INVSENSOR00009 Sensor

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

Tala Harake

Masimo Corporation

Phone: 949-297-7137

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place