Trial Outcomes & Findings for Oxygen Reserve Index: Utility as Early Warning for Desaturation in Morbidly Obese Patients (NCT NCT03021551)

Results Overview

Evaluate the clinical utility of the change in the oxygen reserve index as an early warning of impending arterial oxygen desaturation in Obese patients (30 \< BMI \< 40 kg m-2) and Normal BMI patients (19 \< BMI \< 25 kg m-2).

Recruitment status

COMPLETED

Target enrollment

80 participants

Primary outcome timeframe

1 year

Results posted on

2022-04-19

Participant Flow

Participant milestones

Participant milestones
Measure	Rainbow Sensor Rainbow sensor: Masimo Radical-7 and Root System with ORi parameter in all subjects are enrolled in the test group and receive an Rainbow sensor during their elective surgery.
Overall Study STARTED	80
Overall Study COMPLETED	77
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Rainbow Sensor Rainbow sensor: Masimo Radical-7 and Root System with ORi parameter in all subjects are enrolled in the test group and receive an Rainbow sensor during their elective surgery.
Overall Study Equipment Issues	2
Overall Study Protocol Violation	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Rainbow Sensor n=77 Participants Rainbow sensor: Masimo Radical-7 and Root System with ORi parameter in all subjects are enrolled in the test group and receive an Rainbow sensor during their elective surgery.
Age, Categorical <=18 years	0 Participants n=77 Participants
Age, Categorical Between 18 and 65 years	53 Participants n=77 Participants
Age, Categorical >=65 years	24 Participants n=77 Participants
Sex: Female, Male Female	51 Participants n=77 Participants
Sex: Female, Male Male	26 Participants n=77 Participants
Region of Enrollment United States	77 participants n=77 Participants

PRIMARY outcome

Timeframe: 1 year

Population: In 4 subjects, the device failed initial calibration. In another subject, clinical care constraints precluded completion of the data collection.

Evaluate the clinical utility of the change in the oxygen reserve index as an early warning of impending arterial oxygen desaturation in Obese patients (30 \< BMI \< 40 kg m-2) and Normal BMI patients (19 \< BMI \< 25 kg m-2).

Outcome measures

Outcome measures
Measure	Rainbow Sensor n=72 Participants Rainbow sensor: Masimo Radical-7 and Root System with ORi parameter in all subjects are enrolled in the test group and receive an Rainbow sensor during their elective surgery.
Utility of ORi Providing Added Warning Time Added warning time in Obese	46.5 seconds
Utility of ORi Providing Added Warning Time Added warning time in Normal BMI	87.0 seconds

Adverse Events

Rainbow Sensor

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

Cristina Johnson

Masimo Corporation

Phone: 949-297-7000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60