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CompletedNCT03125005Updated Jul 27, 2017Results posted

Accuracy of Methemoglobin Measurement for Rainbow Universal Pulse Oximeter Sensor

An interventional study of Rainbow Universal Pulse Oximeter Sensor in Healthy, sponsored by Masimo Corporation. Completed at 2 sites in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-07-27.

Sponsored by Masimo Corporation · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 5 years after the study started (first participant enrolled Apr 2012, registered Apr 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
51
Allocation
Not applicable
Ages
18 Years to 50 Years
Sex
All
01

Study summary

In this study, the level of methemoglobin (HbMet) will be increased in a controlled manner by administering sodium nitrite intravenously in healthy volunteers. The accuracy of a noninvasive HbMet sensor will be assessed by comparison to blood measurements from a laboratory analyzer.

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

  • The subject is male or female, aged ≥18 and \<50.
  • The subject is in good general health with no evidence of any medical problems.
  • The subject is fluent in both written and spoken English.
  • The subject has provided informed consent and is willing to comply with the study procedures.

Exclusion criteria

Exclusion Criteria:

  • The subject is obese (BMI>30).
  • The subject has a known history of heart disease, lung disease, kidney or liver disease.
  • Diagnosis of asthma, sleep apnea, or use of CPAP.
  • Subject has diabetes.
  • Subject has a clotting disorder.
  • The subject has a hemoglobinopathy or history of anemia, per subject report or the first blood sample, that in the opinion of the investigator, would make them unsuitable for study participation.
  • The subject has any other serious systemic illness.
  • The subject is a current smoker.
  • Any injury, deformity, or abnormality at the sensor sites that in the opinion of the investigators' would interfere with the sensors working correctly.
  • The subject has a history of fainting or vasovagal response.
  • The subject has a history of sensitivity to local anesthesia or allergy to the study drugs.
  • The subject has a diagnosis of Raynaud's disease.
  • The subject has unacceptable collateral circulation based on exam by the investigator (Allen's test).
  • The subject is pregnant, lactating or trying to get pregnant.
  • The subject has a history of migraine headaches.
  • The subject is currently taking antidepressants.
  • The subject is unable or unwilling to provide informed consent, or is unable or unwilling to comply with study procedures.
  • The subject has any other condition, which in the opinion of the investigators' would make them unsuitable for the study.
05

Study design

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

Study arms

  • Experimental
    Rainbow Universal Pulse Oximeter Sensor

    All subjects will be enrolled in the test group and will receive Rainbow Universal Pulse Oximeter Sensor.

    Device: Rainbow Universal Pulse Oximeter Sensor

Interventions

  • DeviceRainbow Universal Pulse Oximeter Sensor
06

What researchers measure

Primary outcomes

  1. Accuracy of Sensor by Arms Calculation

    Accuracy willl be determined by comparing the noninvasive blood methemoglobin measurement (expressed as a percentage of total hemoglobin) of the pulse oximeter to that obtained from a blood sample and calculating the arithmetic root mean square(Arms) error value.

    Time frame: 5 hours

07

Results

Posted Jun 6, 2017

Participant flow

Participant flow — Overall Study
MilestoneRainbow Universal Pulse Oximeter Sensor
Started51
Completed51
Not completed0

Outcome measures

PrimaryAccuracy of Sensor by Arms Calculation

Accuracy willl be determined by comparing the noninvasive blood methemoglobin measurement (expressed as a percentage of total hemoglobin) of the pulse oximeter to that obtained from a blood sample and calculating the arithmetic root mean square(Arms) error value.

Time frame:
5 hours
Reported as:
Number · Percentage of total hemoglobin
Accuracy of Sensor by Arms Calculation
Percentage of total hemoglobinRainbow Universal Pulse Oximeter Sensor
Accuracy of Sensor by Arms Calculation0.63

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Rainbow Universal Pulse Oximeter Sensor0/51 (0%)0/51 (0%)0/51 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Rainbow Universal Pulse Oximeter Sensor
<=18 years0
Between 18 and 65 years51
>=65 years0
Sex: Female, Male
Sex: Female, Male(Participants)Rainbow Universal Pulse Oximeter Sensor
Female29
Male22
Region of Enrollment
Region of Enrollment(participants)Rainbow Universal Pulse Oximeter Sensor
United States51
08

Study locations

2 sites
  • Masimo Clinical Lab
    Irvine, California 92618, United States
  • University of San Francisco
    San Francisco, California 94117, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 27, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03125005
Lead sponsor
Masimo Corporation
Responsible party
Sponsor
First posted
Apr 24, 2017
Start date
Apr 12, 2012
Primary completion
Jun 21, 2012
Completion
Jun 21, 2012
Results posted
Jun 6, 2017
Last update
Jul 27, 2017

Oversight

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

Not currently enrolling

This study is completed, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.

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