MedTrace Logo

Evaluating Pulse Oximetry Bias in Children With Darker Skin Pigmentation

NCT05617547 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 154

Last updated 2024-04-01

No results posted yet for this study

Summary

In this prospective study, the investigators will enroll 154 children with arterial lines to determine the accuracy of pulse oximeters in children with darker skin pigmentation. Studies in adults suggest pulse oximeters may overestimate the true level of oxygenation in the blood as measured directly by co-oximetry. However, pediatric data are relatively limited. This study, which is funded by the FDA through the Stanford-UCSF (University of California San Francisco) Clinical Excellence in Regulatory Science and Innovation (CERSI) Program, will determine if the error/bias is associated with skin pigmentation and whether the error falls outside FDA standards. The broader purpose of the study is to work toward eliminating health disparities.

Conditions

  • Congenital Heart Disease in Children
  • Cardiomyopathies

Interventions

DIAGNOSTIC_TEST

Pulse Oximeter (Massimo)

The Massimo LNCS (low noise cabled sensors) pulse oximeter will be used to estimate the oxygen saturation and compared to the gold standard, the arterial oxygen saturation in the blood as measured by co-oximetry. The pulse oximeters is FDA cleared for this purpose so patients will not be exposed to any interventions that are not standard of care.

Sponsors & Collaborators

Eligibility

Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-31
Primary Completion
2024-10-01
Completion
2024-10-01
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05617547 on ClinicalTrials.gov