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Pulse Oximetry Accuracy by Skin Color

NCT05692453 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 540

Last updated 2026-01-23

No results posted yet for this study

Summary

This is a prospective, non-randomized, non-blinded comparative study to evaluate the accuracy of pulse oximetry compared to co-oximetry in dark-skinned (Black) compared to lighter-skinned (White) children undergoing anesthesia, using standard FDA performance statistics as measured by mean bias and accuracy root mean squared to evaluate device performance.

Conditions

  • Surgery

Interventions

DIAGNOSTIC_TEST

Arterial blood gas with co-oximetry

1 mL blood sample for ABG-CoOx analysis to obtain co-oximetry measured arterial oxygen saturation (SaO2C) and standard ABG derived arterial oxygen saturation (SaO2S).

Sponsors & Collaborators

  • Brittany Willer

    lead OTHER

Principal Investigators

  • Brittany Willer, MD · Nationwide Children's Hospital

Eligibility

Min Age
2 Years
Max Age
9 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-31
Primary Completion
2027-12-31
Completion
2027-12-31
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 NCT05692453 on ClinicalTrials.gov