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NCT03124836 · ClinicalTrials.gov registry record · NA

Accuracy of Methemoglobin Measurement of Various Rainbow Pulse Oximeter Sensors

A NA study, sponsored by Masimo Corporation.

Completed
Registry status
NA
Development phase
28
Enrollment target

NCT03124836: Completed NA study, sponsored by Masimo Corporation.

NCT03124836 is a NA study that has completed, run by Masimo Corporation. The registered enrollment target is 28 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03124836, a NA study, has completed, sponsored by Masimo Corporation.

COMPLETED
Registry status
NA
Development phase
28 participants
Enrollment target

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 the noninvasive HbMet measurement by a Pulse Oximeter Sensor will be assessed by comparison to blood measurements from a laboratory analyzer.

Primary Outcome

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.In order to obtain the Arms value, the blood sample methemoglobin value is subtracted from the pulse oximeter methemoglobin value for a number of samples, the average of this difference is computed as the bias. The standard deviation of

Interventions

  • DEVICE Pulse Oximeter Sensor

Trial Details

FieldValue
Enrollment Target 28 participants
Start Date 2009-11-18
Est. Completion 2009-12-17
Phase NA
Masimo Corporation

96 total trials

What the finished NCT03124836 record still lists

NCT03124836 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).

The record links to 0 conditions, and to 1 intervention - of which Pulse Oximeter Sensor is the first listed.

NCT03124836 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03124836 about?

NCT03124836 is a clinical study titled "Accuracy of Methemoglobin Measurement of Various Rainbow Pulse Oximeter Sensors". 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 the noninvasive HbMet measurement by a Pulse Oximeter Sensor will be assessed by comparison to blood measurements from a lab...

What is the current status of trial NCT03124836?

This trial is currently completed. It is a NA study. The enrollment target is 28 participants. The study started on 2009-11-18. Estimated completion is 2009-12-17.

What interventions are being tested in trial NCT03124836?

The interventions under investigation include: Pulse Oximeter Sensor (DEVICE).

Who is sponsoring clinical trial NCT03124836?

This trial is sponsored by Masimo Corporation, which has 96 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03124836's enrollment target sits among peer trials

28 1704th of 2000 higher than 293 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03124836, the US trial registry maintained by the National Library of Medicine. NCT03124836 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.