Accuracy of Pulse Oximeters in Profound Hypoxia

Hypoxia Clinical Trial

Official title:

Performance of the Movano Health Ring in a Controlled Hypoxia Study: Prospective Observational Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05920278
• Other study ID #: 153-00381
• Status: Completed
• Start date: October 26, 2022
• Est. completion date: October 27, 2022

Study information

• Verified date: June 2023
• Source: Movano Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The goal of this study was to evaluate the accuracy of pulse oximeters over the range of 70-100%. Two devices were placed on each subject with one on the finger and the other on the fingertip. SpO2 measurements from these devices were compared to sampling of arterial blood during brief stable oxygen desaturation in healthy volunteers to evaluate the claimed range.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: October 27, 2022
• Est. primary completion date: October 27, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 49 Years

Eligibility

Inclusion Criteria:

• Subject is in good general health with no evidence of any medical problems.
• Subject is fluent in both written and spoken English.
• Subject provided written informed consent and is willing to comply with the study procedures.
• Subject is willing to have their skin color assessed.

Exclusion Criteria:

• Subject is obese with a BMI over 30.
• Subject has a known history of heart disease, lung disease, kidney or liver disease.
• Subject has asthma, sleep apnea, or uses a CPAP.
• Subject has diabetes.
• Subject has a clotting disorder, anemia, or in the opinion of the investigator, they would be unsuitable for participation.
• Subject has any other serious system illness.
• Subject is a current smoker.
• Subject has any injury, deformity, or abnormality at the sensor sites that, in the opinion of the investigator, would interfere with the sensors working correctly.
• Subject has a history of fainting or vasovagal response.
• Subject has a sensitivity to local anesthesia.
• Subject has Raynaud's disease.
• Subject has unacceptable collateral circulation based on an exam by the investigator.
• Subject is pregnant, lactating, or trying to get pregnant.
• Subject is unable or unwilling to provide informed consent or is unable or unwilling to comply with the study procedures.
• Subject has any other condition, which in the opinion of the investigator, would make them unsuitable for the study.

Related Conditions & MeSH terms

• Hypoxia

Intervention

Device:
• Pulse oximeter
Devices (2) were placed on the finger and the fingertip. Blood samples were taken at each stable level of oxygenation.

Locations

Country	Name	City	State
United States	Hypoxia Research Laboratory	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
Movano Health	University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	RMSE compared to arterial blood SaO2	Root Mean Squared Error between Movano Ring SpO2 measurement and the arterial blood SaO2 calibrated using arterial blood gas.	2 days

External Links

•   Pulse Oximeters - Premarket Notification Submissions [510(k)s]: Guidance for Industry and Food and Drug Administration Staff | FDA