Pulse Oximetry Accuracy by Skin Color

NCT ID: NCT05692453

Last Updated: 2026-01-23

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 540 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2026-07-31
• Study Completion Date: 2027-12-31

Brief 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.

Detailed Description

This is a prospective, non-randomized, non-blinded comparative study.

There will be no changes to the anesthetic or surgical plan to accommodate this study. Patients undergoing anesthesia will be induced per their anesthetic team. Following endotracheal intubation, the patient will be placed on air (FiO2 21%) at 4 liters per minute fresh gas flow. After a minimum of 3 minutes has elapsed, the anesthesia team will obtain an arterial blood sample of approximately 1 mL. This can be obtained from an arterial line if one is planned for the procedure or already in place by accessing the line per standard procedure. If an arterial line is not placed, the arterial sample will be obtained by percutaneous arterial puncture using ultrasound guidance and a 25-gauge blood gas syringe. The patient's SpO2 will be noted using a pulse oximetry probe placed on the right index finger when the arterial sample is drawn, along with the date/time of sample acquisition. Once the sample is drawn, the patient's anesthetic and surgery will proceed as per his anesthesia team. The arterial sample will be immediately delivered to the Nationwide Children's Hospital laboratory for simultaneous ABG and ABG-CoOx analysis to obtain SaO2S and SaO2C, respectively.

Conditions

Surgery

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

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).

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

ABG-CoOx

Eligibility Criteria

Inclusion Criteria

• Children aged 2-9 years undergoing general anesthesia with or without arterial line placement.

Exclusion Criteria

• Patients with cyanotic congenital heart disease.
• Patients with bleeding disorders.
• Patients taking blood thinners.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 9 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brittany Willer

OTHER

Sponsor Role: lead

Responsible Party

Brittany Willer

Director of Quality Improvement & Safety

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Brittany Willer, MD

Role: PRINCIPAL_INVESTIGATOR

Nationwide Children's Hospital

Locations

Nationwide Children's Hospital

Columbus, Ohio, United States

Countries

United States

Central Contacts

Julie Rice-Weimer, RN

Role: CONTACT

julie.rice-weimer@nationwidechildrens.org

614-355-3142

Catherine Roth, MPH

Role: CONTACT

catherine.roth@nationwidechildrens.org

614-722-2997

Other Identifiers

STUDY00003117

Identifier Type: -

Identifier Source: org_study_id