Trial Outcomes & Findings for Oxygen Reserve Index (ORi) Validation of INVSENSOR00014 (NCT NCT03500341)

Last Updated: 2021-09-08

Results Overview

This study reports ORi specificity, sensitivity and concordance for Masimo's ORi measurement system as compared to PaO2 from blood samples.

Recruitment status

TERMINATED

Target enrollment

33 participants

Primary outcome timeframe

1-5 hours per subject

Results posted on

2021-09-08

Participant Flow

Of the 33 enrolled participants, 16 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 INVSENSOR00014 sensor INVSENSOR00014: Noninvasive pulse oximeter sensor
Overall Study STARTED	16
Overall Study COMPLETED	14
Overall Study NOT COMPLETED	2

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 INVSENSOR00014 sensor INVSENSOR00014: Noninvasive pulse oximeter sensor
Overall Study Withdrawn prior to Completion	2

Baseline Characteristics

Oxygen Reserve Index (ORi) Validation of INVSENSOR00014

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Test Subject n=14 Participants All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00014 sensor INVSENSOR00014: Noninvasive pulse oximeter sensor
Age, Customized < 18 years old	0 Participants n=5 Participants
Age, Customized 18 to 50 years old	14 Participants n=5 Participants
Age, Customized > 50 years old	0 Participants n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	4 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	3 Participants n=5 Participants
Race/Ethnicity, Customized Native American	2 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	3 Participants n=5 Participants
Race/Ethnicity, Customized Asian or Pacific Islander	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1-5 hours per subject

Population: Sufficient number of cases to meet sample size criteria for assessing outcomes was not achieved. The protocol required a minimum of 22 completed subjects. This study was not able to meet this target and therefore the specificity, sensitivity and concordance for Masimo's ORi measurement system could not be defined (primary outcome measure).

This study reports ORi specificity, sensitivity and concordance for Masimo's ORi measurement system as compared to PaO2 from blood samples.

Outcome measures

Outcome data not reported

Adverse Events

Test Subject

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

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