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

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.

Study Overview

• Status: Recruiting
• Conditions: Pediatric ALL; Cardiac Defect

Detailed Description

This multisite, prospective, observational study will be conducted in a population of children under 18 years old who are undergoing cardiac catheterization. The primary aim of the study is to quantify pulse oximeter accuracy in children with varying skin colors. Children undergoing cardiac catheterization are a unique population in which to study pulse oximeter accuracy because they have a wide range of baseline arterial oxygen saturations secondary to their cardiac conditions, allowing for evaluation of pulse oximeter accuracy across a range of arterial oxygen saturations. Children undergoing cardiac catheterization are continuously monitored with pulse oximeters and also have direct measurement of arterial blood oxygen via co-oximeter as part of routine care. The results of this study will contribute much needed knowledge about pulse oximeter accuracy in children to better understand potential clinical implications.

Dimensions of skin colors (melanin index, redness etc) will be objectively measured using spectrophotometry. During and after the catheterization procedure, clinical data already collected during the course of clinical care will be recorded by the study team, including pulse oximeter output and arterial blood oxygen saturation measurement obtained during the procedure. The primary outcome of interest is the difference between the pulse oximeter reading and the direct measurement of arterial blood oxygen.

• Study Type: Observational
• Enrollment (Estimated): 650

Contacts and Locations

• Study Contact: Name: Halley Ruppel, PhD; Phone Number: 267-426-0220; Email: hruppel@nursing.upenn.edu
• Study Contact Backup: Name: Michelle Dunn; Phone Number: 8324445631; Email: medpenn@nursing.upenn.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • Not yet recruiting
      • Columbia University Medical Center
      • Contact: Christopher Petit, MD; Email: cjp2196@cumc.columbia.edu
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • Children's Hospital of Philadelphia
      • Contact: Michael O'Byrne, MD; Email: obyrnem@chop.edu
  • Texas
    • Houston, Texas, United States, 77030
      • Not yet recruiting
      • Texas Children's Hospital
      • Contact: Athar Qureshi, MD; Email: axquresh@texaschildrens.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Children who are old undergoing a cardiac catheterization procedure at one of the data collection sites and is having a procedure that typically involves direct arterial oxygen saturation measurement by co-oximeter from a location reflective of systemic saturation.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pulse Oximeter Bias	Pulse oximeter bias is the difference between the pulse oximeter value (estimated % oxygen saturation measured via pulse oximeter) and the gold standard measure of arterial oxygen saturation (% oxygen saturation in blood sample measured via co-oximeter).	The variables used to calculate Pulse Oximeter Bias are collected once during the cardiac catheterization procedure. This is a cross-sectional observational study; participants are not followed longitudinally.

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Collaborators: Baylor College of Medicine; Children's Hospital of Philadelphia; National Heart, Lung, and Blood Institute (NHLBI); Columbia University
• Investigators: Principal Investigator: Halley Ruppel, PhD, University of Pennsylvania; Principal Investigator: Michael O'Byrne, MD, MSCE, Children's Hospital of Philadelphia

Publications and helpful links

General Publications

• Ruppel H, Huang L, Petit CJ, Qureshi AM, Bonafide CP, Foglia EE, Feldman J, Lane-Fall MB, Lynch JM, Chien A, Dunn M, O'Byrne ML. Protocol for a multisite, observational clinical study of the association between skin colour and pulse oximeter accuracy in children undergoing cardiac catheterisation (PACH study). BMJ Open. 2025 Apr 5;15(4):e100391. doi: 10.1136/bmjopen-2025-100391.

Study record dates

Study Major Dates

• Study Start (Actual): August 14, 2024
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: July 22, 2024
• First Submitted That Met QC Criteria: July 30, 2024
• First Posted (Actual): July 31, 2024

Study Record Updates

• Last Update Posted (Estimated): September 12, 2025
• Last Update Submitted That Met QC Criteria: September 5, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Pulse Oximetry
• Additional Relevant MeSH Terms: Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Leukemia, Lymphoid; Leukemia; Hemic and Lymphatic Diseases; Precursor Cell Lymphoblastic Leukemia-Lymphoma
• Other Study ID Numbers: 854895; R01HL171313-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Per NIH Data Management and Sharing Policy, study data will be contributed to a repository available to other researchers. Study data will be de-identified.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No