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Pulse Oximeter Hypoxia

NCT04562584 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2020-09-24

No results posted yet for this study

Summary

The aim of this project is to test the accuracy of pulse oximeters (devices intended to measure oxygen saturation in blood noninvasively) during mild, moderate and severe hypoxia (a lower-than-normal concentration of oxygen in arterial blood); ie, a range of arterial HbO2 saturations from 100 to down to 70%. This is done by comparing the reading of the pulse oximeter during brief, steady state hypoxia with a gold-standard measurement of blood oxyhemoglobin (hemoglobin carrying oxygen) saturation, that is arterial blood sample processed in a laboratory.

Conditions

  • Oximetry

Interventions

DEVICE

MyHomeDoc

MyHomeDoc device SpO2 measurements and parallel blood gas analysis to determine oxyhemoglobin saturation (SaO2) using an ABL-90 multi-wavelength oximeter.

Sponsors & Collaborators

  • MyHomeDoc Ltd.

    lead INDUSTRY

Principal Investigators

  • Philip E Bickler, Ph.D., M.D. · University of California, San Francisco

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-06-03
Primary Completion
2020-06-04
Completion
2020-06-04
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04562584 on ClinicalTrials.gov