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OpenTrials
Completed

NCT Number: NCT03125135

Accuracy of Noninvasive Pulse Oximeter Sensor (MightySat RX)

In this study, the level of oxygen within the blood will be reduced in a controlled manner by reducing the concentration of oxygen the study volunteer breathes. The accuracy of a noninvasive pulse oximeter sensor will be assessed by comparison to the oxygen saturation measurements from a laboratory blood gas analyzer.

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Key information

Conditions

Healthy

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Masimo Corporation

Irvine, California, 92618, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Competent non-smoking adults

Inclusion criteria

  • Subjects must understand and consent to be in the study.
  • American Society of Anesthesiology Class 1 (Healthy subjects without any systemic disease at all).

Exclusion criteria

  • Subjects who have any systemic disease at all.
  • Subjects who do not understand the study and the risks.
  • Smokers.
  • Subjects who are pregnant.
  • Subjects having either signs or history of peripheral ischemia.
  • Others deemed ineligible by the clinical staff.

Treatment and study plan

MightySat RX Pulse Oximeter Sensor

Device

Noninvasive pulse oximeter finger sensor.

Primary outcomes

  1. Accuracy of Sensor

    Time frame: 1-5 hours

    Accuracy will be determined by comparing the noninvasive blood oxygen saturation measurement of the pulse oximeter to that obtained from a blood sample and calculating the arithmetic root mean square error (Arms) value.

  2. Accuracy of Sensor during motion

    Time frame: 1-5 hours

    Accuracy will be determined by comparing the noninvasive blood oxygen saturation measurement of the pulse oximeter to that obtained from a blood sample during motion conditions and calculating the arithmetic root mean square error (Arms) value.

Sponsors and collaborators

Lead sponsor

Masimo Corporation

Industry

Registry information

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Apr 24, 2017
Registry last updated
Feb 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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