Pulse Oximetry Accuracy by Skin Color

Part of paid clinical trials in Columbus, Ohio.

Sponsor
Brittany Willer
Study ID
NCT05692453
Status
Not Yet Recruiting

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Conditions

  • Surgery

Eligibility Criteria

Sex
ALL
Age
2 Years - 9 Years
Healthy Volunteers
Not accepted

Interventions

  • Arterial blood gas with co-oximetry — DIAGNOSTIC_TEST
    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).

Study Details

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 Dates

Start date
Jul 31, 2026
Status verified
Jan 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
540 participants (estimated)

Primary Outcome Measure

Accuracy of Pulse Oximetry [ Time Frame: Baseline ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Nationwide Children's HospitalColumbusOhio43205-

Find similar trials in Columbus, OH

By research site
Nationwide Children's Hospital· Columbus, OH

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