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Accuracy of Pulse Oximeters With Profound Hypoxia

NCT05322382 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2022-04-18

No results posted yet for this study

Summary

This project aims to test the accuracy of pulse oximeters during mild, moderate, and severe hypoxia, i.e., a range of arterial HbO2 saturation from 100 down to 70%. A typical study will include at least ten subjects (at least 200 necessary data points to meet the ISO 80601-2-61:2017).

Conditions

  • SpO2

Interventions

PROCEDURE

A-line

Subjects breathe air mixtures containing reduced amounts of oxygen to produce the desired level of hypoxemia.

Sponsors & Collaborators

  • CardiacSense Ltd.

    lead INDUSTRY

Principal Investigators

  • Philip Bickler, MD · UCSF Hypoxia Lab

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2021-06-02
Primary Completion
2021-06-03
Completion
2021-06-03

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 NCT05322382 on ClinicalTrials.gov