SPO2 Clinical Trial - Accuracy of Pulse Oximeters With Profound Hypoxia

Status Completed

Clinical Trial 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).

Clinical Trial Description

After local anesthetic injection, a 22-gauge catheter is inserted in one radial artery. Pulse oximeters are attached to fingers, ears, or flat body surfaces. Subjects are in a comfortable semi-recumbent position. Subjects then breathe air mixtures containing reduced amounts of oxygen to produce the desired level of hypoxemia. Stable, safe, and controlled hypoxia is breath-by-breath by breath respiratory gas analysis and a computer program that permits the inspired gas mixture to be adjusted to achieve a level of lung alveolar gas that will achieve the desired degree of saturation. ;

Study Design

Related Conditions & MeSH terms

Hypoxia
SpO2

Clinical Trial Details

NCT number	NCT05322382
Study type	Interventional
Source	CardiacSense Ltd.
Contact
Status	Completed
Phase	N/A
Start date	June 2, 2021
Completion date	June 3, 2021

View Details

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