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Skin Pigment/Pulse Oximeter in Congenital Heart Disease (CHD)

StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 1 year 1 month later Jul 2026 → Aug 31, 2027
Enrollment reduced 74% 92 → 24 participants
See other at-risk trials from Icahn School of Medicine at Mount Sinai

Record History

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  1. Primary and study completion pushed from Jul 2026 to Aug 31, 2027 Show 4 more changesShow less
    • Enrollment reduced: 92 → 24 participants
    • Secondary endpoints: details revised at 3 of 3 entries
    • Study description revised
    • Eligibility criteria shortened, about 1 word
  2. Primary and study completion dates: Dec 2025 to Jul 2026v3
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Sep 2024 to Oct 29, 2024
    • Site details revised
    v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06575270
Lead Sponsor Icahn School of Medicine at Mount Sinai
Conditions
(from sponsor)		 Hypoxemia, Skin Pigment, Congenital Heart Disease
Related terms Heart Defects, Congenital, Hypoxia, Pigmentation Disorders
Enrollment 24 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov