Accuracy of Pulse Oximeters in Profound Hypoxia

NCT05920278 | Completed FDA Device

• 1 other identifier: 153-00381
• Study Type: observational
• Target: 11
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Healthy Adult Volunteers

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

Device: Pulse oximeter

Interventions

Pulse oximeter DEVICE

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

Healthy Adult Volunteers

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Healthy adult participants 18 to 49 years old, of which 2 or 15% of the subject pool is darkly pigmented.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Movano Health: lead
• University of California, San Francisco: collaborator

Study Sites (1)

Hypoxia Research Laboratory

San Francisco, California, 94133, United States

Location

Related Publications (1)

• 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.

  PMID: 38838332 DERIVED

Related Links

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

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Phillip E Bickler, MD, PhD

  University of California at San Francisco (UCSF)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2023
• First Posted: June 27, 2023
• Study Start: October 26, 2022
• Primary Completion: October 27, 2022
• Study Completion: October 27, 2022
• Last Updated: April 18, 2024

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)