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Evaluating the Relationship Between Skin Color and Pulse Oximeter Accuracy in Children

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
4 Weeks to 18 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study checks whether skin color affects how well pulse oximeters measure oxygen in children's blood. It includes children of all skin colors having cardiac catheterization, a procedure that uses a thin tube to check the heart. Researchers will measure skin color and compare pulse oximeter readings with oxygen levels measured in blood samples.

This multisite study seeks to understand whether and how pulse oximeter accuracy varies across children with different skin colors in real world clinical settings. Many factors can affect how well pulse oximeters work; for example, movement and even fingernail polish. Some studies in adults show that skin color may also affect the pulse oximeter reading. In this study, we will explore pulse oximeter accuracy in children of all skin colors who are undergoing cardiac catheterizations. The study will address limitations of prior work by objectively measuring skin color across multiple dimensions of color and comparing the the pulse oximeter reading to the "gold standard" blood sample measurement.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Child is 1 month to 18 years old.
  • Child is having a heart catheter procedure that normally includes testing oxygen in blood from an artery. The sample must reflect oxygen levels in blood going to the body.

Who can't join

  • Child has already taken part in this study.
  • Child has different levels of blue skin color in the arms and legs due to low blood oxygen.
  • Child is getting medicine through a vein to narrow blood vessels before the procedure.
  • Child has a ventricular assist device (VAD), a pump that helps the heart move blood.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Child is between 1 month and 18 years old * Child is undergoing a cardiac catheterization procedure that typically involves direct arterial oxygen saturation measurement by co-oximeter from a location reflective of systemic saturation. Exclusion Criteria: * Child previously participated in the study * Child has differential cyanosis across extremities * Child is receiving an intravenous vasoconstrictor prior to procedure * Child has a ventricular assist device (VAD)

Study sites (3)

NY

PA

TX