Trial Outcomes & Findings for Correlation of Changes in PaO2 and ORi in Adult Patients (NCT NCT03488238)

NCT ID: NCT03488238

Last Updated: 2021-09-20

Results Overview

ORi is an index value without a unit and ORi does not directly measure PaO2. Therefore, sensitivity is calculated to evaluate changes in ORi relative to the changes in PaO2.

• Recruitment status: COMPLETED
• Target enrollment: 31 participants
• Primary outcome timeframe: Less than 30 mins
• Results posted on: 2021-09-20

Participant Flow

Participant milestones

Measure	ORi Sensor All subjects are enrolled in the test group and receive an ORi sensor during their scheduled, general surgery procedure ORi sensor: Noninvasive pulse oximeter sensor that is placed on the finger for measurement of ORi
Overall Study STARTED	31
Overall Study COMPLETED	29
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure	ORi Sensor All subjects are enrolled in the test group and receive an ORi sensor during their scheduled, general surgery procedure ORi sensor: Noninvasive pulse oximeter sensor that is placed on the finger for measurement of ORi
Overall Study Equipment malfunction	1
Overall Study Adverse Event	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	ORi Sensor n=29 Participants All subjects are enrolled in the test group and receive an ORi sensor during their scheduled, general surgery procedure ORi sensor: Noninvasive pulse oximeter sensor that is placed on the finger for measurement of ORi
Age, Categorical <=18 years	0 Participants n=29 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=29 Participants
Age, Categorical >=65 years	18 Participants n=29 Participants
Sex: Female, Male Female	12 Participants n=29 Participants
Sex: Female, Male Male	17 Participants n=29 Participants
Region of Enrollment United States	29 participants n=29 Participants

PRIMARY outcome

Timeframe: Less than 30 mins

Population: 1 subject was excluded as investigator reported unreliable data.

ORi is an index value without a unit and ORi does not directly measure PaO2. Therefore, sensitivity is calculated to evaluate changes in ORi relative to the changes in PaO2.

Outcome measures

Measure	ORi Sensor n=28 Participants All subjects are enrolled in the test group and receive an ORi sensor during their scheduled, general surgery procedure ORi sensor: Noninvasive pulse oximeter sensor that is placed on the finger for measurement of ORi
Sensitivity for Changes in ORi Values as Compared to Corresponding Changes in PaO2 Values.	100 percentage of true positives

PRIMARY outcome

Timeframe: Less than 30 mins

Population: 1 subject was excluded as investigator reported unreliable data.

ORi is an index value without a unit and ORi does not directly measure PaO2. Therefore specificity is calculated to evaluate changes in ORi relative to the changes in PaO2.

Outcome measures

Measure	ORi Sensor n=28 Participants All subjects are enrolled in the test group and receive an ORi sensor during their scheduled, general surgery procedure ORi sensor: Noninvasive pulse oximeter sensor that is placed on the finger for measurement of ORi
Specificity for Changes in ORi Values as Compared to Corresponding Changes in PaO2 Values.	94.38 percentage of true negatives

PRIMARY outcome

Timeframe: Less than 30 minutes

Population: 1 subject was excluded as investigator reported unreliable data.

ORi is an index value without a unit and ORi does not directly measure PaO2. Therefore concordance is calculated to evaluate changes in ORi relative to the changes in PaO2.

Outcome measures

Measure	ORi Sensor n=28 Participants All subjects are enrolled in the test group and receive an ORi sensor during their scheduled, general surgery procedure ORi sensor: Noninvasive pulse oximeter sensor that is placed on the finger for measurement of ORi
Concordance for Changes in ORi Values as Compared to Corresponding Changes in PaO2 Values.	95.05 percentage of accuracy

Adverse Events

ORi Sensor

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	ORi Sensor n=29 participants at risk All subjects are enrolled in the test group and receive an ORi sensor during their scheduled, general surgery procedure ORi sensor: Noninvasive pulse oximeter sensor that is placed on the finger for measurement of ORi
Injury, poisoning and procedural complications Hypotension	3.4% 1/29 • Less than 30 min

Additional Information

Cristina Johnson

Masimo Corporation

Phone: 949-297-7000

Email: clincalresearchdept@masimo.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60