[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100638570":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":20,"locations":21,"responsibleParty":42,"collaborators":20,"id":44,"slug":20,"hasResults":45,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":45,"sex":51,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":20,"studyType":57,"phases":58,"briefSummary":60,"conditions":61,"keywords":20,"overallStatus":64,"whyStopped":20,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":74},{"fullName":5,"class":6},"GE Healthcare","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"All Subjects","EXPERIMENTAL","Participants participating in this study will be connected to SpO2 sensors. SpO2 data will be independently collected from each sensor and paired with simultaneous arterial blood sample SaO₂ values. The protocol is consistent with the ISO 80601-2-61 pulse oximetry standard.",[13],"Device: SpO2 Sensor",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","SpO2 Sensor","SpO2 sensors use red and infrared LED light to estimate the arterial oxygen saturation.",[9],null,[22],{"facility":23,"status":20,"city":24,"state":25,"zip":26,"country":27,"cosmosGeoPoint":28,"geoPoint":33,"contacts":34},"University of Nebraska Medical Center Children's Hospital","Omaha","Nebraska","68114","United States",{"type":29,"coordinates":30},"Point",[31,32],-95.94043,41.25626,{"lat":32,"lon":31},[35,40],{"name":36,"role":37,"phone":38,"phoneExt":20,"email":39},"Michael Facciolo, MD","CONTACT","402-671-6325","mfacciolo@childrensnebraska.org",{"name":36,"role":41,"phone":20,"phoneExt":20,"email":20},"PRINCIPAL_INVESTIGATOR",{"type":43,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","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":55,"type":56},180,"ESTIMATED","INTERVENTIONAL",[59],"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.",[62,63],"SpO2 (Peripheral Oxygen Saturation) Measurement Validation","SpO2","NOT_YET_RECRUITING","2026-06-29",{"date":67,"type":68},"2026-07-01","ACTUAL",{"date":70,"type":56},"2026-06-15",{"date":72,"type":56},"2027-12-31",{"name":5,"class":6},1]