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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

92 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-10-29

Study Completion Date

2025-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study on Clinical Prognosis, Risk Factors and Genetic Basis of Congenital Heart Disease

NCT01669057

Congenital Heart Disease

COMPLETED

Identification of Heritable CTEPH

NCT03579862

Chronic Thromboembolic Pulmonary Hypertension

UNKNOWN

National Cohort Study of Idiopathic and Heritable Pulmonary Arterial Hypertension

NCT01907295

Pulmonary Arterial Hypertension

UNKNOWN

Genes Associated With Development of Pulmonary Arterial Hypertension in Patients With Congenital Shunt Lesions

NCT02691689

Heart Defects, Congenital Pulmonary Arterial Hypertension Genetic Testing

RECRUITING NA

Antecedents of Hypertension: Role of Race and Stress

NCT00005238

Cardiovascular Diseases Heart Diseases Hypertension

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hypoxemia Skin Pigment Congenital Heart Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Pediatric Patients with Congenital Heart Disease

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.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Pediatric patients (age less than 18 years old) with a diagnosis of CHD (cyanotic or acyanotic) who are presenting for cardiac surgery under general anesthesia with planned arterial access.

Exclusion Criteria

* Age greater than 18 years old
* Emergency surgery
* Significant preoperative anemia (hemoglobin \<8.0 g/dL)
* Preoperative hemodynamic instability (i.e., \>1 vasoactive infusions or mechanical circulatory support)
* The presence of any colored nail polish on the planned site of pulse oximeter placement, planned use of any intravenous dyes intraoperatively, and patient, parent, or guardian refusal.

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No