NCT05692453

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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
540

participants targeted

Target at P75+ for all trials

Timeline
17mo left

Started Jul 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 11, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 20, 2023

Completed
3.4 years until next milestone

Study Start

First participant enrolled

July 1, 2026

Expected
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

January 23, 2026

Status Verified

January 1, 2026

Enrollment Period

1.4 years

First QC Date

January 11, 2023

Last Update Submit

January 21, 2026

Conditions

Surgery

Outcome Measures

Primary Outcomes (1)

  • Accuracy of Pulse Oximetry

    Accuracy of pulse oximetry readings (SpO2) as compared with arterial oxygen saturations measured by arterial blood gas with co-oximetry (ABG-CoOx).

    Baseline

Interventions

Arterial blood gas with co-oximetryDIAGNOSTIC_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).

Also known as: ABG-CoOx

Eligibility Criteria

Age2 Years - 9 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children undergoing surgery at Nationwide Children's Hospital.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

MeSH Terms

Interventions

Blood Gas Analysis

Intervention Hierarchy (Ancestors)

Blood Chemical AnalysisClinical Chemistry TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisRespiratory Function TestsDiagnostic Techniques, Respiratory SystemInvestigative Techniques

Study Officials

  • Brittany Willer, MD

    Nationwide Children's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Julie Rice-Weimer, RN

CONTACT

614-355-3142julie.rice-weimer@nationwidechildrens.org

Catherine Roth, MPH

CONTACT

614-722-2997catherine.roth@nationwidechildrens.org

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director of Quality Improvement & Safety

Study Record Dates

First Submitted

January 11, 2023

First Posted

January 20, 2023

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

January 23, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)