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NCT06575270 · ClinicalTrials.gov registry record
Skin Pigment/Pulse Oximeter in Congenital Heart Disease (CHD)
A clinical trial of Congenital Heart Disease and Hypoxemia, sponsored by Icahn School of Medicine at Mount Sinai.
- Recruiting
- Registry status
- 92
- Enrollment target
- 1
- Study location
NCT06575270: Recruiting study of Congenital Heart Disease and Hypoxemia, sponsored by Icahn School of Medicine at Mount Sinai.
NCT06575270 is a study of Congenital Heart Disease and Hypoxemia that is actively recruiting participants, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 92 participants, below the 473-participant average among 63 other Congenital Heart Disease trials with a reported enrollment target (81% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06575270, a study of Congenital Heart Disease and Hypoxemia, is actively recruiting participants, sponsored by Icahn School of Medicine at Mount Sinai.
- RECRUITING
- Registry status
- 92 participants
- Enrollment target
- 1
- Study location
Study Summary
Recent retrospective studies have demonstrated differences between pulse oximeter values (SpO2) and measured arterial oxygen saturation (SaO2) in patients identifying as Black or Hispanic. These retrospective studies have limitations because self-reported race is likely not an accurate metric for level of skin pigmentation and the retrospective nature of these studies may impact the accuracy of simultaneous measures of arterial oxygen saturation and pulse oximeter values. The few prospective studies that have evaluated this issue have utilized color-matching techniques to quantify skin pigmentation, and fewer studies have directly measured skin pigmentation in relation it to pulse oximeter accuracy. The aim of this study is to prospectively measure pulse oximeter accuracy in relation to measured levels of skin pigmentation in the congenital heart disease population.
Primary Outcome
Pulse oximeter accuracy as it relates to level of skin pigmentation as measured by color spectrophotometry. Pulse oximeter accuracy will be measured using the Accuracy Root Mean Squared (ARMS), mean bias, and proportional bias (Bland-Altman).
Conditions Studied
Study Locations (1)
New York
- Mount Sinai Hospital - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 92 participants |
| Start Date | 2024-10-29 |
| Est. Completion | 2026-07 |
What NCT06575270 shows while recruiting
NCT06575270 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 92 participants, a relatively small participant target, below the 473-participant average among 63 other Congenital Heart Disease trials with a reported enrollment target (81% lower).
The record links to 3 conditions, with Congenital Heart Disease appearing as the primary indexed condition, and to 0 interventions.
NCT06575270 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT06575270 about?
NCT06575270 is a clinical study titled "Skin Pigment/Pulse Oximeter in Congenital Heart Disease (CHD)". Recent retrospective studies have demonstrated differences between pulse oximeter values (SpO2) and measured arterial oxygen saturation (SaO2) in patients identifying as Black or Hispanic. These retrospective studies have limitations because self-reported race is likely not an accurate metric for le...
What is the current status of trial NCT06575270?
This trial is currently recruiting. The enrollment target is 92 participants. The study started on 2024-10-29. Estimated completion is 2026-07.
What conditions does trial NCT06575270 study?
This clinical trial studies the following conditions: Congenital Heart Disease, Hypoxemia, Skin Pigment.
Who is sponsoring clinical trial NCT06575270?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06575270 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Congenital Heart Disease
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 NCT06575270's enrollment target sits among peer trials
92 32nd of 63 higher than 32 of 63 other Congenital Heart Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Congenital Heart Disease 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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