[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06529575":3,"trial-entities:NCT06529575":110,"trial-summary:NCT06529575":115},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":20,"study_type":22,"primary_purpose":14,"phases":23,"enrollment_info":24,"interventions":27,"primary_outcomes":28,"secondary_outcomes":33,"sex":34,"minimum_age":35,"maximum_age":36,"healthy_volunteers":37,"eligibility_criteria":38,"std_ages":48,"locations":51,"central_contacts":90,"overall_officials":99,"references":104,"see_also_links":109},"NCT06529575","854895","Evaluating the Relationship Between Skin Color and Pulse Oximeter Accuracy in Children","RECRUITING","2028-12","2025-09","2025-09-12","2024-08-14","University of Pennsylvania","OTHER",null,"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.","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.\n\nDimensions 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.",[18,19],"Pediatric ALL","Cardiac Defect",[21],"Pulse Oximetry","OBSERVATIONAL",[],{"count":25,"type":26},650,"ESTIMATED",[],[29],{"measure":30,"description":31,"timeFrame":32},"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.",[],"ALL","4 Weeks","18 Years",false,{"inclusion":39,"exclusion":42,"raw_text":47},[40,41],"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.",[43,44,45,46],"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)","Inclusion Criteria:\n\n* Child is between 1 month and 18 years old\n* 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.\n\nExclusion Criteria:\n\n* Child previously participated in the study\n* Child has differential cyanosis across extremities\n* Child is receiving an intravenous vasoconstrictor prior to procedure\n* Child has a ventricular assist device (VAD)",[49,50],"CHILD","ADULT",[52,66,78],{"facility":53,"status":54,"city":55,"state":55,"zip":56,"country":57,"contacts":58,"geoPoint":63},"Columbia University Medical Center","NOT_YET_RECRUITING","New York","10032","United States",[59],{"name":60,"role":61,"email":62},"Christopher Petit, MD","CONTACT","cjp2196@cumc.columbia.edu",{"lat":64,"lon":65},40.71427,-74.00597,{"facility":67,"status":7,"city":68,"state":69,"zip":70,"country":57,"contacts":71,"geoPoint":75},"Children's Hospital of Philadelphia","Philadelphia","Pennsylvania","19104",[72],{"name":73,"role":61,"email":74},"Michael O'Byrne, MD","obyrnem@chop.edu",{"lat":76,"lon":77},39.95238,-75.16362,{"facility":79,"status":54,"city":80,"state":81,"zip":82,"country":57,"contacts":83,"geoPoint":87},"Texas Children's Hospital","Houston","Texas","77030",[84],{"name":85,"role":61,"email":86},"Athar Qureshi, MD","axquresh@texaschildrens.org",{"lat":88,"lon":89},29.76328,-95.36327,[91,95],{"name":92,"role":61,"phone":93,"email":94},"Halley Ruppel, PhD","267-426-0220","hruppel@nursing.upenn.edu",{"name":96,"role":61,"phone":97,"email":98},"Michelle Dunn","8324445631","medpenn@nursing.upenn.edu",[100,102],{"name":92,"affiliation":12,"role":101},"PRINCIPAL_INVESTIGATOR",{"name":103,"affiliation":67,"role":101},"Michael O'Byrne, MD, MSCE",[105],{"pmid":106,"type":107,"citation":108},"40187780","DERIVED","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\u002Fbmjopen-2025-100391.",[],{"nct_id":4,"conditions":111,"biomarkers":114},[112,113],"Acute Lymphoblastic Leukemia","Cardiac defects",[],{"nct_id":4,"found":116,"summary":117,"prompt_version":127},true,{"design":118,"status":119,"heading":120,"summary":121,"follow_up":122,"word_count":123,"commitments":124,"compensation":125,"drugs_mentioned":126},"This is an observational study involving about 650 children. It is not testing a new treatment, but rather observing existing medical practices.","completed","Evaluating Pulse Oximeter Accuracy and Skin Color in Children","This study is looking at how accurate pulse oximeters (devices that measure oxygen in your blood through your skin) are for children with different skin colors. Sometimes, skin color might affect how well these devices work. Researchers will compare pulse oximeter readings to a more precise blood test measurement during a cardiac catheterization procedure (a common heart procedure). This study aims to understand if skin color impacts pulse oximeter accuracy in children aged 1 month to 18 years who are already undergoing this procedure. The goal is to improve our understanding of how these important medical devices work for all children.","This is a cross-sectional study, meaning data is collected once during the cardiac catheterization procedure. Participants are not followed long-term.",101,"If your child participates, the study team will record information already collected during their cardiac catheterization procedure, including pulse oximeter readings and blood oxygen levels. They will also objectively measure your child's skin color.","Not stated in the trial record.",[],"v2"]