Accuracy of Pulse Oximeters in Profound Hypoxia

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.

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Key information

Conditions

Hypoxia Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year–49 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hypoxia Research Laboratory

San Francisco, California, 94133, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pulse Oximeter

Device

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

Primary outcomes

RMSE compared to arterial blood SaO2

Time frame: 2 days

Root Mean Squared Error between Movano Ring SpO2 measurement and the arterial blood SaO2 calibrated using arterial blood gas.

Sponsors and collaborators

Lead sponsor

Movano Health

Industry

Collaborators

University of California, San Francisco

Registry information

Official study title

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

Important dates

Study start: 2022
Primary completion: 2022
Study completion: 2022
First posted: Jun 27, 2023
Registry last updated: Apr 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed