Accuracy of Pulse Oximeters With Profound Hypoxia

Consolidated Research, Inc.1 site in 1 country30 target enrollmentNovember 9, 2022

ConditionsHypoxemia

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Hypoxemia
Sponsor: Consolidated Research, Inc.
Enrollment: 30
Locations: 1
Primary Endpoint: Saturation level measurement
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The goal of this clinical trial is the acquisition of photoplethysmography signals during periods of profound hypoxia. The study is designed in accordance with ISO 80601- 2-61,2ed:2017-12 & 2018-02.

Registry

clinicaltrials.gov

Start Date

November 9, 2022

End Date

November 9, 2024

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Consolidated Research, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

•Pregnancy -

Outcomes

Primary Outcomes

Saturation level measurement

Time Frame: Within 12 months of subject recruitment

Induction of hypoxia by having subjects breathe mixtures of nitrogen, room air, and carbon dioxide to allow measurement of oxyhemoglobin saturation between 70-100%. Each plateau level of oxyhemoglobin saturation was maintained for at least 30 seconds or until reference pulse oximeters readings were stable