An observational study in Hypoxemia, Skin Pigment and Congenital Heart Disease, sponsored by Icahn School of Medicine at Mount Sinai. Recruiting at 1 site in United States. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2026-09-25.
Sponsored by Icahn School of Medicine at Mount Sinai · Observational
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.
This is a prospective observational study aiming to evaluate the relationship between pulse oximeter accuracy to the measured level of skin pigmentation in pediatric patients with congenital heart disease (CHD). These patients live with varying levels of hypoxemia, making them an ideal study population to investigate this critical patient safety issue. The study population will be pediatric patients (age \<18 years old) with a diagnosis of congenital heart disease presenting for cardiac surgery at the Mount Sinai Hospital. These patient's will undergo surgery as per protocol, as if they were not in a research study, but will have their skin pigment measured using a non-invasive device (color spectrophotometer) prior to surgery. As part of the normal surgery protocols, arterial blood gas samples will be completed. The measured oxygen levels (SaO2) on arterial blood gas will be compared to the pulse oximeter value using simultaneous measurements to ensure the measures are concurrent. After cardiopulmonary bypass is initiated for the surgery, the subject's involvement in the study will be completed.
1,076 studies on the registry are indexed under Hypoxia; 213 are open to participants now.
This study's planned enrollment of 24 is below the median of 79 across 277 observational studies indexed under Hypoxia.
Browse Hypoxia studies →Icahn School of Medicine at Mount Sinai is the lead sponsor of 776 studies on the registry; 176 are open to participants now.
Of its 125 completed or terminated interventional studies of FDA-regulated products, 83 (66%) have results posted.
Counted across the registry records on this site, refreshed daily.
Pediatric patients with a past medical history of congenital heart disease presenting for cardiac surgery under general anesthesia with anticipated arterial vascular access.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
No intervention will take place in this observational study. All patients will have their skin pigment measured using a color spectrophotometer and color matching techniques (Fitzpatrick Scale, Monk Skin Tone Scale). Two pulse oximeters will be utilized and pulse oximeter readings will be compared to simultaneous measured arterial saturations. After cardiopulmonary bypass is initiated for the surgery, the subject's involvement in the study will be completed.
Level of Skin Pigmentation
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).
Time frame: Day 1 of study participation
Fitzpatrick Skin Tone Scale
Pulse Oximeter Accuracy in measuring skin pigmentation as measured by Fitzpatrick Skin Tone Scale Pulse oximeter accuracy as it relates to level of skin pigmentation as measured by Fitzpatrick Scale. Scale from I-VI, with higher number indicating darker skin tone
Time frame: Day 1 of study participation
Monk Skin Tone Scale
Pulse oximeter accuracy as it relates to level of skin pigmentation as measured by Monk Skin Tone Scale. Scale from 1-10, higher numbers indicates darker skin tone.
Time frame: Day 1 of study participation
Number of participants who experience at least one episode of occult hypoxemia
Incidence of occult hypoxemia, defined as SpO2 ≥92% despite SaO2≤88%, as it relates to measured skin pigment and incidence of occult hypoxemia will be described. Incidence will be measured by assessing the total number of participants who experience at least one episode of occult hypoxemia.
Time frame: Day 1 of study participation
Plan to share: Yes — All of the individual participant data collected during the trial, after deidentification.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: Upon study completion and in accordance with any peer-reviewed journal requirements.
Access criteria: Researchers who provide a methodologically sound proposal. To achieve aims in the approved proposal. Proposals should be directed to garrett.burnett@mountsinai.org. To gain access, data requestors will need to sign a data access agreement.
No publications or documents are linked to this record.
Started Oct 2024 (actual). Primary completion is estimated for Aug 2027, 34 months after the start.
Of 125 non-industry observational studies under Hypoxia, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 74. This study's planned 34 months is above that.
Counting every sponsor, half of 155 studies reached it within 14 months; a quarter within 3 and three quarters within 46.
Since we started tracking on Sep 25, 2026, the dates moved once, on Sep 25, 2026: primary completion Jul 2026 → Aug 2027 and completion Jul 2026 → Aug 2027.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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