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Accuracy of Evie Ring Pulse Oximeter in Profound Hypoxia

NCT06101654 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 11

Last updated 2024-03-13

No results posted yet for this study

Summary

The goal of this study was to evaluate the accuracy of pulse oximeters over the range of 70-100% per ISO 80601-2-61:2019. Four devices were placed on each subject with two on each index finger at the base and two on each index finger at 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

Interventions

DEVICE

Pulse oximeter

Devices (4) were placed on the finger and the fingertip of both index fingers. Blood samples were taken at each stable level of oxygenation.

Sponsors & Collaborators

Principal Investigators

  • Philip Bickler, MD, PhD · University of California at San Francisco (UCSF)

Eligibility

Min Age
18 Years
Max Age
49 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-01-09
Primary Completion
2024-01-10
Completion
2024-01-10
FDA Device
Yes

Countries

  • United States

Study Locations

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06101654 on ClinicalTrials.gov