Accuracy of Pulse Oximeters in Profound Hypoxia

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

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.

Study Overview

• Status: Completed
• Conditions: Hypoxia
• Intervention / Treatment: Device: Pulse oximeter

• Study Type: Observational
• Enrollment (Actual): 11

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94133
      • Hypoxia Research Laboratory

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy Adult Volunteers; Minimum of ten (10) subjects meeting the eligibility criteria.	Device: Pulse oximeter; Devices (2) were placed on the finger and the fingertip. Blood samples were taken at each stable level of oxygenation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Movano Health
• Collaborators: University of California, San Francisco
• Investigators: Principal Investigator: Phillip E Bickler, MD, PhD, University of California at San Francisco (UCSF)

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): October 26, 2022
• Primary Completion (Actual): October 27, 2022
• Study Completion (Actual): October 27, 2022

Study Registration Dates

• First Submitted: June 16, 2023
• First Submitted That Met QC Criteria: June 16, 2023
• First Posted (Actual): June 27, 2023

Study Record Updates

• Last Update Posted (Actual): April 18, 2024
• Last Update Submitted That Met QC Criteria: April 16, 2024
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory; Hypoxia
• Other Study ID Numbers: 153-00381

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No