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NCT05692453 | Not yet recruiting | Surgery


Pulse Oximetry Accuracy by Skin Color
Sponsor:

Brittany Willer

Information provided by (Responsible Party):

Brittany Willer

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

Surgery

Intervention/treatment

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 Type : Observational
Estimated Enrollment : 540 participants
Official Title : Pulse Oximetry Accuracy by Skin Color
Actual Study Start Date : June 2024
Estimated Primary Completion Date : December 2025
Estimated Study Completion Date : December 2025

Information not available for Arms and Intervention/treatment

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

Pulse Oximetry Accuracy by Skin Color

Location Details


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Pulse Oximetry Accuracy by Skin Color

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Locations


Not yet recruiting

United States, Ohio

Nationwide Children's Hospital

Columbus, Ohio, United States, 43205

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