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NOT YET RECRUITING
NCT05692453

Pulse Oximetry Accuracy by Skin Color

Sponsor: Brittany Willer

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

2 Years - 9 Years

Study Type

OBSERVATIONAL

Enrollment

540

Start Date

2026-07

Completion Date

2027-12

Last Updated

2026-01-23

Healthy Volunteers

No

Conditions

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).

Locations (1)

Nationwide Children's Hospital

Columbus, Ohio, United States