Accuracy of Noninvasive Pulse Oximeter Sensor (MightySat RX)

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Device: MightySat RX Pulse Oximeter Sensor

• Registration Number: NCT03125135
• Lead Sponsor: Masimo Corporation

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11-12
• Primary Completion: 2014-12-17
• Study Completion: 2014-12-17
• Study First Submitted: 2017-04-14
• Study First Submitted QC: 2017-04-20
• Study First Posted: 2017-04-24
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-29
• Last Update Posted: 2021-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Test Subject	MightySat RX Pulse Oximeter Sensor	All subjects are enrolled into the test group and all subjects receive the MightySat RX Pulse Oximeter Sensor.

Primary Outcome Measures

Name	Time	Method
Accuracy of Sensor	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.
Accuracy of Sensor during motion	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.

Trial Locations

Locations (1)

Masimo Corporation; 🇺🇸 Irvine, California, United States