CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 53 enrolled
Drug / intervention
Masimo Rainbow Sensorsdevice
Likely dose
Not stated in record
Key inclusion· 7
  • ✓Age 18 to 50 years
  • ✓Weight ≥110 lbs
  • ✓Hemoglobin ≥11 g/dL
  • ✓Resting heart rate 45–85 bpm
Key exclusion· 26
  • ✕Positive pregnancy test (hCG)
  • ✕BMI >35
  • ✕History of fainting, syncope, or loss of consciousness during blood draw, or fear of blood draws
  • ✕Known drug or alcohol abuse, or recreational drug use

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05636098
NCT05636098N/ACompleted
CompareCT.gov

Repeatability and Reproducibility of Oxygen Reserve Index (ORi)

Masimo Corporation·interventional·Posted Dec 5, 2022·Updated Apr 6, 2025

In Brief

A clinical study evaluating Masimo Rainbow Sensors for Healthy. Completed, enrolled 53 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2023202420252026
First PostedDec 5, 2022
Enrollment StartNov 7, 2022
Primary CompletionJan 11, 2023
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 3.6 years ago

Interventions

Masimo Rainbow Sensorsdevice

Noninvasive pulse oximeter sensor