Pulse Oximetry Accuracy by Skin Color

Sponsor
Brittany Willer (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05692453
Collaborator
(none)
540
1
33.1
16.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Arterial blood gas with co-oximetry

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
540 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Pulse Oximetry Accuracy by Skin Color
Anticipated Study Start Date :
Mar 1, 2023
Anticipated Primary Completion Date :
Dec 1, 2025
Anticipated Study Completion Date :
Dec 1, 2025

Outcome Measures

Primary Outcome Measures

  1. Accuracy of Pulse Oximetry [Baseline]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
2 Years to 9 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Nationwide Children's Hospital Columbus Ohio United States 43205

Sponsors and Collaborators

  • Brittany Willer

Investigators

  • Principal Investigator: Brittany Willer, MD, Nationwide Children's Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Brittany Willer, Director of Quality Improvement & Safety, Nationwide Children's Hospital
ClinicalTrials.gov Identifier:
NCT05692453
Other Study ID Numbers:
  • STUDY00003117
First Posted:
Jan 20, 2023
Last Update Posted:
Jan 20, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes

Study Results

No Results Posted as of Jan 20, 2023