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NCT06022523 Clinical Trial

Accuracy of Pulse Oximeters With Profound Hypoxia

Hypoxemia Clinical Trial

Official title:
Accuracy of Pulse Oximeters With Profound Hypoxia

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06022523
Other study ID # 21-344376
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 9, 2022
Est. completion date November 9, 2024

Study information
Verified date August 2023
Source Consolidated Research, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 30
Est. completion date November 9, 2024
Est. primary completion date November 9, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria: - Exclusion Criteria: Pregnancy -

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Data acquisition using DT-400 pulse oximetry system
Acquisition of photopleth data during profound hypoxia using a Consolidated Research DT-400 pulse oximetry system.

Locations
Country Name City State
United States Consolidated Research, Inc. Cleveland Ohio

Sponsors (1)
Lead Sponsor Collaborator
Consolidated Research, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Saturation level measurement 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 Within 12 months of subject recruitment
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