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NCT05617547 · ClinicalTrials.gov registry record
Evaluating Pulse Oximetry Bias in Children With Darker Skin Pigmentation
A clinical trial of Cardiomyopathies and Congenital Heart Disease in Children, sponsored by Stanford University.
- Recruiting
- Registry status
- 154
- Enrollment target
- 1
- Study location
NCT05617547 is a study of Cardiomyopathies and Congenital Heart Disease in Children that is actively recruiting participants, run by Stanford University. The registered enrollment target is 154 participants, below the 626-participant average among 17 other Cardiomyopathies trials with a reported enrollment target (75% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05617547, a study of Cardiomyopathies and Congenital Heart Disease in Children, is actively recruiting participants, sponsored by Stanford University.
- RECRUITING
- Registry status
- 154 participants
- Enrollment target
- 1
- Study location
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 Studied
Interventions
- DIAGNOSTIC_TEST Pulse Oximeter (Massimo)
Study Locations (1)
California
- Lucile Packard Children's Hospital - Palo Alto
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 154 participants |
| Start Date | 2022-08-31 |
| Est. Completion | 2024-10-01 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05617547
The ClinicalTrials.gov registry entry for NCT05617547 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 154 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 626-participant average among 17 other Cardiomyopathies trials with a reported enrollment target (75% lower). The listed sponsor is Stanford University, which has 1,744 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Cardiomyopathies appearing as the primary indexed condition, and to 1 intervention - of which Pulse Oximeter (Massimo) is the first listed.
NCT05617547 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT05617547 about?
NCT05617547 is a clinical study titled "Evaluating Pulse Oximetry Bias in Children With Darker Skin Pigmentation". 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...
What is the current status of trial NCT05617547?
This trial is currently recruiting. The enrollment target is 154 participants. The study started on 2022-08-31. Estimated completion is 2024-10-01.
What conditions does trial NCT05617547 study?
This clinical trial studies the following conditions: Cardiomyopathies, Congenital Heart Disease in Children.
What interventions are being tested in trial NCT05617547?
The interventions under investigation include: Pulse Oximeter (Massimo) (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT05617547?
This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05617547 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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