Pulse Oximetry Accuracy by Skin Color
ConditionSurgery
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age2-9
SponsorBrittany Willer
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Children aged 2-9 years undergoing general anesthesia with or without arterial line placement.
Disqualifiers
Patients with cyanotic congenital heart disease.
Patients with bleeding disorders.
Patients taking blood thinners.
Trial population
Children undergoing surgery at Nationwide Children's Hospital.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Arterial blood gas with co-oximetry
Diagnostic test1 mL blood sample for ABG-CoOx analysis to obtain co-oximetry measured arterial oxygen saturation (SaO2C) and standard ABG derived arterial oxygen saturation (SaO2S).
Treatment groups
No treatment groups listed
Trial outcomes
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).
Time frame
BaselineSponsors and contacts
Click on the lead sponsor to view all of their trials.
Brittany Willer
Lead sponsor
Nationwide Children's Hospital
Sponsor institution
Source ClinicalTrials.gov
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