Accuracy of Pulse Oximeters With Profound Hypoxia

Not Applicable

Recruiting

• Conditions: Hypoxemia

• Registration Number: NCT06022523
• Lead Sponsor: Consolidated Research, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-09
• Study First Submitted: 2022-11-30
• Status Verified: 2023-08
• Study First Submitted QC: 2023-08-30
• Last Update Submitted: 2023-08-30
• Study First Posted: 2023-09-05
• Last Update Posted: 2023-09-05
• Primary Completion: 2024-11-09
• Study Completion: 2024-11-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Exclusion Criteria

Pregnancy -

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Saturation level measurement	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

Trial Locations

Locations (1)

Consolidated Research, Inc.; 🇺🇸 Cleveland, Ohio, United States