Accuracy of Pulse Oximeters With Profound Hypoxia

SpO2 Clinical Trial

Official title:

Accuracy of Pulse Oximeters With Profound Hypoxia - Test Protocol

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05322382
• Other study ID #: 008_SPO_CV_OS_USF
• Status: Completed
• Phase: N/A
• Start date: June 2, 2021
• Est. completion date: June 3, 2021

Study information

• Verified date: April 2022
• Source: CardiacSense Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: June 3, 2021
• Est. primary completion date: June 3, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

1. The subject is male or female, aged =18 and <50.

2. The subject is in good general health with no evidence of any medical problems.

3. The subject is fluent in both written and spoken English.

4. The subject has provided informed consent and is willing to comply with the study procedures.

Exclusion Criteria:

1. The subject is obese (BMI>30).

2. The subject has a known history of heart disease, lung disease, kidney or liver disease.

3. Diagnosis of asthma, sleep apnea, or use of CPAP.

4. Subject has diabetes.

5. Subject has a clotting disorder.

Related Conditions & MeSH terms

• Hypoxia
• SpO2

Intervention

Procedure:
• A-line
Subjects breathe air mixtures containing reduced amounts of oxygen to produce the desired level of hypoxemia.

Locations

Country	Name	City	State
United States	University of California at San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
CardiacSense Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy of pulse oximeter with profound hypoxia	Perform accurate measurement of a range of arterial HbO2 saturation from 100 to down to 70% during mild, moderate, and severe hypoxia.	2 days