An interventional study of Masimo Rainbow Sensors in Healthy, sponsored by Masimo Corporation. Completed at 1 site in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-06.
Sponsored by Masimo Corporation · Not applicable, Interventional, and Other
This study is designed to evaluate the repeatability and reproducibility of ORi using an investigational Masimo rainbow sensor and FDA cleared rainbow sensors connected to the Masimo Radical-7 pulse oximeter and Masimo Root monitor in healthy volunteers as the subjects undergo a controlled hyperoxygenation protocol.
Masimo Corporation is the lead sponsor of 103 studies on the registry; 1 is open to participants now.
Of its 78 completed or terminated interventional studies of FDA-regulated products, 65 (83%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
All subjects who are enrolled into the test group and participate in data collection receive the noninvasive Masimo Rainbow Sensors.
Device: Masimo Rainbow Sensors
Noninvasive pulse oximeter sensor
Repeatability of Masimo Rainbow Sensors
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.
Time frame: 1-1.5 hours
Reproducibility of Masimo Rainbow Sensors
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.
Time frame: 1-1.5 hours
| Milestone | Masimo Rainbow Sensors |
|---|---|
| Started | 53 |
| Completed | 29 |
| Not completed | 24 |
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.
| Mean Absolute Error (Unitless) | Masimo Rainbow Sensors |
|---|---|
| Repeatability of Masimo Rainbow Sensors | 0.05 (0 to 1) |
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.
| Mean Absolute Error (Unitless) | Masimo Rainbow Sensors |
|---|---|
| Reproducibility of Masimo Rainbow Sensors | 0.07 (0 to 1) |
Collected over 1-3 hours. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Masimo Rainbow Sensors | 0/53 (0%) | 0/53 (0%) | 0/53 (0%) |
| Age, Categorical(Participants) | Masimo Rainbow Sensors |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 29 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | Masimo Rainbow Sensors |
|---|---|
| Female | 10 |
| Male | 19 |
| Race (NIH/OMB)(Participants) | Masimo Rainbow Sensors |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 5 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 10 |
| White | 4 |
| More than one race | 1 |
| Unknown or Not Reported | 9 |
| Region of Enrollment(participants) | Masimo Rainbow Sensors |
|---|---|
| United States | 29 |
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This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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