[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07168798":3,"trial-entities:NCT07168798":82,"trial-summary:NCT07168798":85},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":27,"interventions":30,"primary_outcomes":37,"secondary_outcomes":42,"sex":46,"minimum_age":47,"maximum_age":48,"healthy_volunteers":49,"eligibility_criteria":50,"std_ages":58,"locations":60,"central_contacts":70,"overall_officials":71,"references":76,"see_also_links":81},"NCT07168798","25-023147","SpO2 Accuracy in Children","Evaluation of SpO2 Accuracy in Children With Various Skin Color","ENROLLING_BY_INVITATION","2028-11-01","2025-11","2025-11-21","2025-11-12","Nihon Kohden","INDUSTRY",false,"Evaluation of SpO2 Accuracy in Children with Various Skin Color","Pulse oximeters, which estimate blood oxygen levels, are routinely utilized for monitoring. However, research has shown that these devices may provide higher readings for individuals with darker skin tones as compared to individuals with lighter skin tones. This inaccuracy can result in unnoticed or untreated low oxygen levels, particularly affecting racial and ethnic minorities. It is beneficial for patients and healthcare providers to evaluate the accuracy of pulse oximeter oxygen saturation (SpO2) readings from pulse oximeters sold in the U.S. This study test the Nihon Kohden pulse oximeter and SpO2 sensors in neonatal and pediatric patients.",[19],"Hypoxemia",[21,22,23],"Spo2","Pulse oximetry","skin tone","OBSERVATIONAL",null,[],{"count":28,"type":29},180,"ESTIMATED",[31],{"type":32,"name":33,"description":34,"armGroupLabels":35},"DEVICE","Pulse oximeter","OLV-4201 pulse oximeter with sensors: TL-272T3, TL-274T3 and TL-273T3",[36],"Enrolled subjects",[38],{"measure":39,"description":40,"timeFrame":41},"SpO2 accuracy","Evaluate the accuracy of Nihon Kohden SpO2 in measuring blood oxygen levels in children with varying skin tones","24 hours",[43],{"measure":44,"description":45,"timeFrame":41},"SpO2 to SaO2 agreement","Evaluate the agreement between Nihon Kohden SpO2 and arterial oxygen saturation (SaO2) in children with varying skin tones","ALL","0 Days","12 Years",true,{"inclusion":51,"exclusion":53,"raw_text":57},[52],"Children aged 0 - 12 who are admitted to the CICU with or plan to have an indwelling arterial line for standard care",[54,55,56],"Patients with elevated levels of methemoglobin and carboxyhemoglobin, or anemia.","Patients with prolonged hypotension at the time of enrollment.","Patients with ductal-dependent congenital cardiac disease.","Inclusion Criteria:\n\n* Children aged 0 - 12 who are admitted to the CICU with or plan to have an indwelling arterial line for standard care\n\nExclusion Criteria:\n\n* Patients with elevated levels of methemoglobin and carboxyhemoglobin, or anemia.\n* Patients with prolonged hypotension at the time of enrollment.\n* Patients with ductal-dependent congenital cardiac disease.",[59],"CHILD",[61],{"facility":62,"city":63,"state":64,"zip":65,"country":66,"geoPoint":67},"Childrens Hospital of Philadelphia","Philadelphia","Pennsylvania","19104","United States",{"lat":68,"lon":69},39.95238,-75.16362,[],[72],{"name":73,"affiliation":74,"role":75},"Maryam Y Naim, M.D., MSCE","Children's Hospital of Philadelphia","PRINCIPAL_INVESTIGATOR",[77],{"pmid":78,"type":79,"citation":80},"33326721","RESULT","Sjoding MW, Dickson RP, Iwashyna TJ, Gay SE, Valley TS. Racial Bias in Pulse Oximetry Measurement. N Engl J Med. 2020 Dec 17;383(25):2477-2478. doi: 10.1056\u002FNEJMc2029240. No abstract available.",[],{"nct_id":4,"conditions":83,"biomarkers":84},[19],[],{"nct_id":4,"found":15,"summary":25,"prompt_version":25}]