CClinicalTrials.gg
CompletedNCT05636098Updated Apr 6, 2025Results posted

Repeatability and Reproducibility of Oxygen Reserve Index (ORi)

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

Phase
Not applicable
Study type
Interventional
Enrollment
53
Allocation
Not applicable
Ages
18 Years to 50 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Subject is 18 to 50 years of age.
  • Subject weighs a minimum of 110 lbs.
  • Hemoglobin value ≥ 11 g/dL.
  • Baseline heart rate ≥ 45 bpm and ≤ 85 bpm.
  • Blood Pressure: Systolic BP ≤ 140 mmHg and ≥ 90 mmHg, Diastolic BP ≤ 90 mmHg and ≥ 50 mmHg, and if systolic BP is lower than 100 mmHg and/or diastolic BP is lower than 60 mmHg, subject passes an orthostatic blood pressure test.
  • CO value ≤ 3.0% FCOHb.
  • Subject is able to read and communicate in English and understands the study and the risks involved

Exclusion criteria

Exclusion Criteria:

  • Subject has a positive hCG test.
  • Subject has a BMI > 35.
  • Subject has a history of fainting (vasovagal syncope), blacking out or losing consciousness during or after a blood draw, or has a fear of blood draws.
  • Subject has open wounds, inflamed tattoos or piercings, and/or has any visible healing wounds that a medical professional determines may place them at an increased risk for participation. *
  • Subject has known drug or alcohol abuse.
  • Subject uses recreational drugs. *
  • Subject experiences frequent or severe headaches and/or migraine headaches, migraine auras, altitude sickness, and/or headaches accompanied by visual changes or sensitivity to light or sound.
  • Subject has experienced a concussion or head injury with loss of consciousness within the past 12 months.
  • Subject has any history of a stroke, myocardial infarction (heart attack), and/or seizures.
  • Subject has any chronic bleeding disorder (e.g., hemophilia).
  • Subject has taken anticoagulant medication within the past 30 days (excluding nonsteroidal anti-inflammatory drugs (NSAIDS)).
  • Subject has donated blood within the past 4 weeks.
  • Subject has Wolff-Parkinson-White Syndrome or Stokes-Adams Syndrome.
  • Subject has any cardiac dysrhythmia (e.g., atrial fibrillation) and has not received clearance from their physician to participate. *
  • Subject has a known neurological and/or psychiatric disorder (e.g., schizophrenia, bipolar disorder, Multiple Sclerosis, Huntington's disease) that interferes with the subject's level of consciousness. *
  • Subject has taken opioid pain medication 24 hours before the study.
  • Subject has any active signs and/or symptoms of infectious disease (e.g., Hepatitis, HIV, Tuberculosis, Flu, Malaria, Measles, etc.). *
  • Subject is taking medications known to treat any type of infectious disease.
  • Subject has either signs or history of peripheral ischemia or carpal tunnel syndrome.
  • Subject has had invasive surgery within the past year, including but not limited to major dental surgery, appendectomy, plastic surgery, jaw surgery, major ENT surgery, major abdominal and/or pelvic surgery, heart surgery, or thoracic surgery. *
  • Subject has symptoms of congestion, head cold, or other illnesses.
  • Subject has been in a severe car accident(s) or a similar type of accident(s) requiring hospitalization within the past 12 months.
  • Subject has any cancer or history of cancer (not including skin cancer). *
  • Subject has chronic unresolved asthma, lung disease (including COPD) and/or respiratory disease.
  • Subject is allergic to Lidocaine, chlorhexidine, latex, adhesives, or plastic.
  • Subject has a heart condition, insulin-dependent diabetes, or uncontrolled hypertension.
  • Subject has delivered vaginally, has had a pregnancy terminated, a miscarriage with hospitalization or had a C-section within the past 6 months.
  • Subject intends on participating in any heavy lifting, repetitive movement of their wrist (including riding a motorcycle, tennis), exercise (working out, riding a bike, riding a skateboard, etc.), or any activity that will put additional stress on the wrist within 24 hours following a study that involves an arterial line.
  • Subject has any medical condition which in the judgment of the investigator and/or medical staff, renders them ineligible for participation in this study or subject is deemed ineligible by the discretion of investigator/study staff.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
53 participants (actual)

Study arms

  • Experimental
    Masimo Rainbow Sensors

    All subjects who are enrolled into the test group and participate in data collection receive the noninvasive Masimo Rainbow Sensors.

    Device: Masimo Rainbow Sensors

Interventions

  • DeviceMasimo Rainbow Sensors

    Noninvasive pulse oximeter sensor

06

What researchers measure

Primary outcomes

  1. 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

  2. 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

07

Results

Posted Apr 6, 2025

Participant flow

Participant flow — Overall Study
MilestoneMasimo Rainbow Sensors
Started53
Completed29
Not completed24

Outcome measures

PrimaryRepeatability 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
Reported as:
Mean · Mean Absolute Error (Unitless)
Repeatability of Masimo Rainbow Sensors
Mean Absolute Error (Unitless)Masimo Rainbow Sensors
Repeatability of Masimo Rainbow Sensors0.05 (0 to 1)
PrimaryReproducibility 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
Reported as:
Mean · Mean Absolute Error (Unitless)
Reproducibility of Masimo Rainbow Sensors
Mean Absolute Error (Unitless)Masimo Rainbow Sensors
Reproducibility of Masimo Rainbow Sensors0.07 (0 to 1)

Adverse events

Collected over 1-3 hours. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Masimo Rainbow Sensors0/53 (0%)0/53 (0%)0/53 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Masimo Rainbow Sensors
<=18 years0
Between 18 and 65 years29
>=65 years0
Sex: Female, Male
Sex: Female, Male(Participants)Masimo Rainbow Sensors
Female10
Male19
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Masimo Rainbow Sensors
American Indian or Alaska Native0
Asian5
Native Hawaiian or Other Pacific Islander0
Black or African American10
White4
More than one race1
Unknown or Not Reported9
Region of Enrollment
Region of Enrollment(participants)Masimo Rainbow Sensors
United States29
08

Study locations

1 site
  • Masimo Corporation
    Irvine, California 92618, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Oct 3, 2022

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 6, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05636098
Lead sponsor
Masimo Corporation
Responsible party
Sponsor
First posted
Dec 5, 2022
Start date
Nov 7, 2022
Primary completion
Jan 11, 2023
Completion
Jan 11, 2023
Results posted
Apr 6, 2025
Last update
Apr 6, 2025

Oversight

FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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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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