Trial Outcomes & Findings for Desaturation Validation of INVSENSOR00031 (NCT NCT03783780)

Last Updated: 2019-12-17

Results Overview

Performance of the sensors will be determined by comparing the noninvasive oxygen saturation measurement (SpO2) of the pulse oximeter sensors to the arterial oxygen saturation (SaO2) value obtained from a reference blood sample and calculating the Arithmetic root mean square (ARMS) value during non-motion.

Recruitment status

COMPLETED

Study phase

Target enrollment

21 participants

Primary outcome timeframe

1-5 hours

Results posted on

2019-12-17

Participant Flow

Participant milestones

Participant milestones
Measure	INVSENSOR00031 All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00031 sensor during motion and non-motion.
Overall Study STARTED	21
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	INVSENSOR00031 All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00031 sensor during motion and non-motion.
Overall Study Withdrawn prior to completion	1

Baseline Characteristics

One subject was withdrawn prior to completing study procedures.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	INVSENSOR00031 n=21 Participants All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00031 sensor during motion and non-motion.
Age, Categorical <=18 years	0 Participants n=20 Participants • One subject was withdrawn prior to completing study procedures.
Age, Categorical Between 18 and 65 years	20 Participants n=20 Participants • One subject was withdrawn prior to completing study procedures.
Age, Categorical >=65 years	0 Participants n=20 Participants • One subject was withdrawn prior to completing study procedures.
Sex: Female, Male Female	11 Participants n=20 Participants • One subject was withdrawn prior to completing study procedures.
Sex: Female, Male Male	9 Participants n=20 Participants • One subject was withdrawn prior to completing study procedures.
Race/Ethnicity, Customized White	10 Participants n=20 Participants • One subject was withdrawn prior to completion of study procedures.
Race/Ethnicity, Customized Hispanic	5 Participants n=20 Participants • One subject was withdrawn prior to completion of study procedures.
Race/Ethnicity, Customized Asian or Pacific Islander	2 Participants n=20 Participants • One subject was withdrawn prior to completion of study procedures.
Race/Ethnicity, Customized African American	3 Participants n=20 Participants • One subject was withdrawn prior to completion of study procedures.
Region of Enrollment United States	21 participants n=21 Participants

PRIMARY outcome

Timeframe: 1-5 hours

Population: Only ten subjects, out of the 20 who participated in the study, underwent testing for this non-motion outcome measure.

Outcome measures

Outcome measures
Measure	INVSENSOR00031 n=10 Participants All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00031 sensor.
Oxygen Saturation (SpO2) Accuracy of Sensor by Arms Calculation During Non-motion	1.33 % of oxygen saturated hemoglobin

SECONDARY outcome

Timeframe: 1-5 hours

Population: Ten subjects were excluded from data analysis from this outcome measure due to insufficient training of the study staff on the motion testing procedure.

Outcome measures

Outcome measures
Measure	INVSENSOR00031 n=10 Participants All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00031 sensor.
Oxygen Saturation (SpO2) Accuracy of Sensor by Arms Calculation During Motion	2.16 % of oxygen saturated hemoglobin

Adverse Events

INVSENSOR00031

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	INVSENSOR00031 n=21 participants at risk All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00031 sensor during motion and non-motion.
Injury, poisoning and procedural complications Scraped skin	4.8% 1/21 • 1 week

Additional Information

Tala Harake

Masimo

Phone: 1-949-297-7100

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place