Trial Outcomes & Findings for Repeatability and Reproducibility of Oxygen Reserve Index (ORi) (NCT NCT05636098)

NCT ID: NCT05636098

Last Updated: 2025-04-06

Results Overview

The Repeatability of ORi for Masimo Rainbow Sensors refers to the ability of a sensor to consistently produce the same readings under similar conditions (hyperoxia level). 1. A Repeatability Error is defined as the difference between ORi measurements from one sensor at different time points under similar operating conditions. 2. The mean of the absolute of all the repeatability errors obtained across different conditions and sensors is represented as the Repeatability of ORi. 3. Since ORi is a unit-less parameter, the Repeatability of ORi is also unit-less. ORi values range from 0-1, with 0 indicating normoxia while 1 indicating moderate to high hyperoxia.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 53 participants
• Primary outcome timeframe: 1-1.5 hours
• Results posted on: 2025-04-06

Participant Flow

Participant milestones

Measure	Masimo Rainbow Sensors All subjects who are enrolled into the test group and participate in data collection receive the noninvasive Masimo Rainbow Sensors. Masimo Rainbow Sensors: Noninvasive pulse oximeter sensor
Overall Study STARTED	53
Overall Study COMPLETED	29
Overall Study NOT COMPLETED	24

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Repeatability and Reproducibility of Oxygen Reserve Index (ORi)

Baseline characteristics by cohort

Measure	Masimo Rainbow Sensors n=29 Participants All subjects who are enrolled into the test group and participate in data collection receive the noninvasive Masimo Rainbow Sensors. Masimo Rainbow Sensors: Noninvasive pulse oximeter sensor
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	29 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	5 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	10 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	9 Participants n=5 Participants
Region of Enrollment United States	29 participants n=5 Participants

PRIMARY outcome

Timeframe: 1-1.5 hours

Population: 2 subjects not included in analysis for device setting errors.

The Repeatability of ORi for Masimo Rainbow Sensors refers to the ability of a sensor to consistently produce the same readings under similar conditions (hyperoxia level).

1. A Repeatability Error is defined as the difference between ORi measurements from one sensor at different time points under similar operating conditions.

2. The mean of the absolute of all the repeatability errors obtained across different conditions and sensors is represented as the Repeatability of ORi.

3. Since ORi is a unit-less parameter, the Repeatability of ORi is also unit-less. ORi values range from 0-1, with 0 indicating normoxia while 1 indicating moderate to high hyperoxia.

Outcome measures

Measure	Masimo Rainbow Sensors n=27 Participants All subjects who are enrolled into the test group and participate in data collection receive the noninvasive Masimo Rainbow Sensors. Masimo Rainbow Sensors: Noninvasive pulse oximeter sensor
Repeatability of Masimo Rainbow Sensors	0.05 Mean Absolute Error (Unitless) Interval 0.0 to 1.0

PRIMARY outcome

Timeframe: 1-1.5 hours

Population: 5 subjects not included in analysis due to device setting errors.

The Reproducibility of ORi for Masimo Rainbow Sensors refers to the ability of two sensors to produce similar ORi results when measurements are taken under the same conditions (hyperoxia level).

1. A Reproducibility Error is the difference between 2 ORi measurements obtained from each of a pair of sensors at the same time and under the same operating conditions.

2. The mean of absolute of all the reproducibility errors are represented as the Reproducibility of ORi.

3. Since ORi is a unit-less parameter, the Reproducibility of ORi is also unit-less. ORi values ranges from 0-1, with 0 indicating normoxia while 1 indicating moderate to high hyperoxia.

Outcome measures

Measure	Masimo Rainbow Sensors n=22 Participants All subjects who are enrolled into the test group and participate in data collection receive the noninvasive Masimo Rainbow Sensors. Masimo Rainbow Sensors: Noninvasive pulse oximeter sensor
Reproducibility of Masimo Rainbow Sensors	0.07 Mean Absolute Error (Unitless) Interval 0.0 to 1.0

Adverse Events

Masimo Rainbow Sensors

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

Ahmed Alghazi

Masimo Corporation

Phone: 949-297-7000

Email: studies@masimo.com

Results disclosure agreements

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