Pediatric ALLPACHNCT06529575
Evaluating the Relationship Between Skin Color and Pulse Oximeter Accuracy in Children
An observational study of Pediatric ALL and Cardiac Defect, run by University of Pennsylvania at 3 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 4 weeks to 18 years
- Conditions the study is for
- Pediatric ALL, Cardiac Defect
- How many people
- 650 participants
- Where
- 3 sitesUnited States
- Study dates
- 14 Aug 2024to Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 weeks to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Not yet recruiting
Texas Children's Hospital
Houston, Texas, 77030
Athar Qureshi, MD, axquresh@texaschildrens.org
- Not yet recruiting
Columbia University Medical Center
New York, New York, 10032
Christopher Petit, MD, cjp2196@cumc.columbia.edu
- Recruiting
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Michael O'Byrne, MD, obyrnem@chop.edu
About this study
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.
Read the 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.
- Conditions
- Pediatric ALL, Cardiac Defect
- Keywords
- Pulse Oximetry
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2024
- Study start14 Aug 2024
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pediatric ALLStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 650 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital of Philadelphia, Baylor College of Medicine, Columbia University, National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Halley Ruppel, PhD, Principal investigator, University of PennsylvaniaMichael O'Byrne, MD, MSCE, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06529575
- Sponsor's protocol ID
- 854895
- Other IDs
- R01HL171313-01
- Acronym
- PACH
- Status last verified
- Sep 2026
- First submitted
- 22 Jul 2024
- Last updated
- 24 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
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.
PubMed 40187780
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Relationship Between Skin Color and Pulse Oximeter Accuracy in Children
- ClinicalTrials.gov ID
- NCT06529575
- Acronym / sponsor ID
- PACH / 854895
- Conditions
- Pediatric ALL, Cardiac Defect
- Keywords
- Pulse Oximetry
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 650 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Children's Hospital of Philadelphia, Baylor College of Medicine, Columbia University, National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 14 Aug 2024 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 31 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 4 weeks to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pulse Oximeter Bias
Time frame: 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.
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Derived from this study: PubMed 40187780Ruppel 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Halley Ruppel, PhD principal investigator
University of Pennsylvania
Michael O'Byrne, MD, MSCE principal investigator
Children's Hospital of Philadelphia
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatric ALL and Cardiac Defect, run by University of Pennsylvania at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Halley Ruppel, PhD (267-426-0220, hruppel@nursing.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulse Oximeter Bias (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06529575, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.