Accuracy of Pulse Oximeters in Profound Hypoxia

NCT ID: NCT05920278

Last Updated: 2024-04-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 11 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-10-26
• Study Completion Date: 2022-10-27

Brief 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.

Conditions

Hypoxia

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Healthy Adult Volunteers

Minimum of ten (10) subjects meeting the eligibility criteria.

Pulse oximeter

Intervention Type: DEVICE

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

Interventions

Pulse oximeter

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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of California, San Francisco

OTHER

Sponsor Role: collaborator

Movano Health

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Phillip E Bickler, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California at San Francisco (UCSF)

Locations

Hypoxia Research Laboratory

San Francisco, California, United States

Countries

United States

References

Mastrototaro JJ, Leabman M, Shumate J, Tompkins KL. Performance of a Wearable Ring in Controlled Hypoxia: A Prospective Observational Study. JMIR Form Res. 2024 Jun 5;8:e54256. doi: 10.2196/54256.

Reference Type: DERIVED

PMID: 38838332 (View on PubMed)

Related Links

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/pulse-oximeters-premarket-notification-submissions-510ks-guidance-industry-and-food-and-drug

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

Other Identifiers

153-00381

Identifier Type: -

Identifier Source: org_study_id