NCT05322382

Accuracy of Pulse Oximeters With Profound Hypoxia

Accuracy of Pulse Oximeters With Profound Hypoxia - Test Protocol

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: CardiacSense Ltd. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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).

Detailed 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.

Conditions

• SpO2

Interventions

Type	Name	Description
PROCEDURE	A-line	Subjects breathe air mixtures containing reduced amounts of oxygen to produce the desired level of hypoxemia.

Timeline

• Start date: 2021-06-02
• Primary completion: 2021-06-03
• Completion: 2021-06-03
• First posted: 2022-04-11
• Last updated: 2022-04-18

Locations

1 site across 1 country: United States