Trial Outcomes & Findings for Oxygen Reserve Index (ORi) Validation of INVSENSOR00029 (NCT NCT03678103)

Last Updated: 2021-09-30

Results Overview

ORi is an index value without a unit. Sensitivity, specificity, and concordance are calculated to evaluate changes in ORi relative to the changes in PaO2 at 150 mmHg.

Recruitment status

COMPLETED

Target enrollment

57 participants

Primary outcome timeframe

1-5 hours

Results posted on

2021-09-30

Participant Flow

Of the 57 enrolled participants, 30 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 INVSENSOR00029 sensor INVSENSOR00029: Noninvasive pulse oximeter sensor
Overall Study STARTED	30
Overall Study COMPLETED	26
Overall Study NOT COMPLETED	4

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 INVSENSOR00029 sensor INVSENSOR00029: Noninvasive pulse oximeter sensor
Overall Study Withdrawn prior to completion	4

Baseline Characteristics

Oxygen Reserve Index (ORi) Validation of INVSENSOR00029

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Test Subject n=26 Participants All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00029 sensor INVSENSOR00029: Noninvasive pulse oximeter sensor
Age, Customized < 18 years old	0 Participants n=93 Participants
Age, Customized 18 to 50 years old	26 Participants n=93 Participants
Age, Customized > 50 years old	0 Participants n=93 Participants
Sex: Female, Male Female	11 Participants n=93 Participants
Sex: Female, Male Male	15 Participants n=93 Participants
Race/Ethnicity, Customized Asian or Pacific Islander	4 Participants n=93 Participants
Race/Ethnicity, Customized Black or African American	5 Participants n=93 Participants
Race/Ethnicity, Customized Caucasian	7 Participants n=93 Participants
Race/Ethnicity, Customized Hispanic	8 Participants n=93 Participants
Race/Ethnicity, Customized Middle Eastern	1 Participants n=93 Participants
Race/Ethnicity, Customized Native American	1 Participants n=93 Participants

PRIMARY outcome

Timeframe: 1-5 hours

ORi is an index value without a unit. Sensitivity, specificity, and concordance are calculated to evaluate changes in ORi relative to the changes in PaO2 at 150 mmHg.

Outcome measures

Outcome measures
Measure	Test Subject n=26 Participants All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00029 sensor INVSENSOR00029: Noninvasive pulse oximeter sensor
Sensitivity for Changes in ORi Values as Compared to Corresponding Changes in PaO2 Values.	93.63 percentage of true positives

PRIMARY outcome

Timeframe: 1-5 hours

ORi is an index value without a unit. Sensitivity, specificity, and concordance are calculated to evaluate changes in ORi relative to the changes in PaO2 at 150 mmHg.

Outcome measures

Outcome measures
Measure	Test Subject n=26 Participants All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00029 sensor INVSENSOR00029: Noninvasive pulse oximeter sensor
Specificity for Changes in ORi Values as Compared to Corresponding Changes in PaO2 Values.	86.96 percentage of true negatives

PRIMARY outcome

Timeframe: 1-5 hours

ORi is an index value without a unit. Sensitivity, specificity, and concordance are calculated to evaluate changes in ORi relative to the changes in PaO2 at 150 mmHg.

Outcome measures

Outcome measures
Measure	Test Subject n=26 Participants All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00029 sensor INVSENSOR00029: Noninvasive pulse oximeter sensor
Corcordance for Changes in ORi Values as Compared to Corresponding Changes in PaO2 Values	90.59 percentage of accuracy

Adverse Events

Test Subject

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Test Subject n=30 participants at risk All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00029 sensor INVSENSOR00029: Noninvasive pulse oximeter sensor
Surgical and medical procedures Sensitivity at arterial line site	3.3% 1/30 • 1 to 5 hours
Surgical and medical procedures Vasovagal	3.3% 1/30 • 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