[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"spo2-peripheral-oxygen-saturation-measurement-validation\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:spo2-peripheral-oxygen-saturation-measurement-validation":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":5},"100638570","spo2-infant-and-pediatric-study-100638570",false,"NCT07615738","SpO2 Infant and Pediatric Study","Assessment of TruSignal SpO2 Form, Fit and Clinical Performance With Infant and Child Patients","SpO2 Peds","Inclusion Criteria:\n\n* subjects are 1-23 months (infant cohort) or 2-12 years old (child cohort)\n* requiring arterial blood samples per the site's standard of care.\n\nExclusion Criteria:\n\n* Fractional Methemoglobinemia (FMetHb \\>2%) or Fractional carboxyhemoglobinemia (FCOHb \\>3%), within 24 hours of arterial blood draw.\n* Severe anemia (tHb \\\u003C7g\u002FdL) within 4 hours prior to arterial blood gas draw.\n* Hematocrit (Hct) \\\u003C25 within 4 hours prior to arterial blood gas draw.\n* Patients with injuries, deformities, or abnormalities which may prevent proper application of the sensor.\n* Patients on Extracorporeal Membrane Oxygenation (ECMO).\n* Patients receiving point of care (POC) testing for blood gases.\n* Patients with diseases\u002Fconditions that may cause differential (or reverse differential) cyanosis including, but not limited to:\n* Patent ductus arteriosus with pulmonary arterial hypertension.\n* Pulmonary hypertension and left-heart abnormalities aortic arch hypoplasia, interrupted aortic arch, critical coarctation, and critical aortic stenosis.\n* Children with transposition of the great arteries (TGA) and coarctation of the aorta or interrupted aortic arch, and TGA with suprasystemic pulmonary vascular resistance.\n* At the discretion of the principal investigator or designee due to the subject health condition.","ALL","29 Days","12 Years",{"count":21,"type":22},180,"ESTIMATED","INTERVENTIONAL",[25],"NA","This study evaluates the pulse oximetry (SpO₂) sensor for clinical performance, form, and fit in hospitalized infants and children (28 days to 12 years). It compares SpO₂ measurements from the device to arterial oxygen saturation (SaO₂) values from arterial CO-oximetry, and assesses the reliability of usable data, performance across skin tones, and user feedback.",[28,29],"SpO2 (Peripheral Oxygen Saturation) Measurement Validation","SpO2","NOT_YET_RECRUITING","2026-06-29",{"date":33,"type":34},"2026-07-01","ACTUAL",{"date":36,"type":22},"2026-06-15",{"date":38,"type":22},"2027-12-31",{"name":40,"class":41},"GE Healthcare","INDUSTRY"]