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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: Recruiting study of Cardiomyopathies and Congenital Heart Disease in Children, sponsored by Stanford University.
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. According to ClinicalTrials.gov, the official US trial registry.
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 |
What NCT05617547 shows while recruiting
NCT05617547 is an observational study that tracks outcomes without assigning an intervention. The registered 154 participants enrollment target is mid-sized for trials with a published cap, below the 626-participant average among 17 other Cardiomyopathies trials with a reported enrollment target (75% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05617547's enrollment target sits among peer trials
154 11th of 17 higher than 7 of 17 other Cardiomyopathies trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cardiomyopathies trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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