Trial Outcomes & Findings for Desaturation Validation of INVSENSOR00028 (NCT NCT03704636)

Last Updated: 2021-07-15

Results Overview

The Trending accuracy of the INVSENSOR00028 will be evaluated relative to the reference value calculated from the arterial and venous blood measurements.

Recruitment status

COMPLETED

Study phase

Target enrollment

46 participants

Primary outcome timeframe

1-5 hours

Results posted on

2021-07-15

Participant Flow

Of the 46 enrolled participants, 23 met inclusion criteria and proceeded to the study. The remainder of the enrolled participants include screen failures and subjects that did not proceed due to time constraints.

Participant milestones

Participant milestones
Measure	Test Subject All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00028 sensor. INVSENSOR00028: Noninvasive pulse oximeter sensor
Overall Study STARTED	23
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Test Subject All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00028 sensor. INVSENSOR00028: Noninvasive pulse oximeter sensor
Overall Study Inadequate Venous Flow	3

Baseline Characteristics

Desaturation Validation of INVSENSOR00028

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Test Subject n=20 Participants All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00028 sensor. INVSENSOR00028: Noninvasive pulse oximeter sensor
Age, Customized < 18 years old	0 Participants n=5 Participants
Age, Customized 18 to 50 years old	20 Participants n=5 Participants
Age, Customized > 50 years old	0 Participants n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Race/Ethnicity, Customized Asian or Pacific Islander	2 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	8 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	6 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	4 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1-5 hours

Population: There is no apparent trend in either the Brachial or Flexor RSO2 data with respect to the control. Since there is no measurable trend, a numerical value for Trending Accuracy (as defined in the protocol) cannot be accurately determined.

The Trending accuracy of the INVSENSOR00028 will be evaluated relative to the reference value calculated from the arterial and venous blood measurements.

Outcome measures

Outcome data not reported

Adverse Events

Test Subject

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Test Subject n=20 participants at risk All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00028 sensor. INVSENSOR00028: Noninvasive pulse oximeter sensor
Injury, poisoning and procedural complications Hematoma	5.0% 1/20 • 1 to 5 hours
Injury, poisoning and procedural complications Sensitivity at arterial line site	5.0% 1/20 • 1 to 5 hours
Injury, poisoning and procedural complications Lightheadedness	5.0% 1/20 • 1 to 5 hours

Additional Information

Chelsea Frank

Masimo Corporation

Phone: 949-297-7000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place