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Accuracy of the EvieMED Ring Pulse Oximeter in Profound Hypoxia

NCT06459206 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 12

Last updated 2024-06-14

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 the International Organization for Standardization (ISO) 80601-2-61:2019. Four test devices were placed on each subject on the left or right hand with two at the finger base and two at the fingertip. Motion equipment was used to control motion of the test devices. In addition, two test devices were placed on the contralateral hand on the base of a finger and also on the fingertip. Finally, a test wrist device was placed on either the left or right wrist. 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 base and the fingertip of two right or left fingers and placed in motion for the duration of the study. Devices (3) were placed on the contralateral side and maintained motionless for the duration of the of study. 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
2024-06-11
Primary Completion
2024-06-13
Completion
2024-06-13
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT06459206 on ClinicalTrials.gov