[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100513883":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":25,"locations":33,"responsibleParty":51,"collaborators":11,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":60,"sex":61,"minAge":11,"maxAge":62,"enrollmentInfo":63,"targetDuration":11,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":73,"overallStatus":36,"whyStopped":11,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"University Children's Hospital, Zurich","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Single Arm","EXPERIMENTAL",null,[13],"Diagnostic Test: Near infrared-spectroscopy",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":11},"DIAGNOSTIC_TEST","Near infrared-spectroscopy","Comparison of regional intestinal oxygen saturation (measured with near infrared-spectroscopy) and indirect intraabdominal pressure measurement (bladder pressure) in muscle-relaxed, sedated patients compared to awake, non-sedated patients.",[9],[21],{"name":22,"affiliation":23,"role":24},"Hannah R Neeser, MD","University Children's Hospital of Zurich","PRINCIPAL_INVESTIGATOR",[26,30],{"name":22,"role":27,"phone":28,"phoneExt":11,"email":29},"CONTACT","+41442667111","hannah.neeser@kispi.uzh.ch",{"name":31,"role":27,"phone":28,"phoneExt":11,"email":32},"Ueli Moehrlen, MD","ueli.moehrlen@kispi.uzh.ch",[34],{"facility":35,"status":36,"city":37,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"University Children's Hospital Zurich","RECRUITING","Zurich","Canton of Zurich","8032","Switzerland","CH",{"type":43,"coordinates":44},"Point",[45,46],8.55,47.36667,{"lat":46,"lon":45},[49],{"name":50,"role":27,"phone":28,"phoneExt":11,"email":29},"Hannah R Neeser",{"type":52,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100513883","comparison-of-bladder-pressure-versus-regional-intestinal-tissue-oxygenation-in-infants-100513883",false,"NCT05971264","Comparison of Bladder Pressure Versus Regional Intestinal Tissue Oxygenation in Infants","BPvsNIRS","Inclusion Criteria:\n\n* Prepped and consented for laparoscopic pyeloplasty or minimal PSARP with perineal or vestibular fistula or lateral thoracotomy for the correction of esophageal atresia\n* Age of 12 months old or less at operation\n* Legal custodian gives consent\n\nExclusion Criteria:\n\n* Anterior abdominal wall thickness greater than 12 mm measured on preoperative MRI imaging if available\n* Patients planned for additional intestinal surgeries or non-standard pyeloplasty, e.g. pyeloplasty with nephrostoma\n* Patients planned for laparoscopic pyeloplasty whose intraoperative urine sample shows pathological results\n* Patients with esophageal atresia who experience pulmonary decompensation and need urgent surgery for fistula clipping",true,"ALL","12 Months",{"count":64,"type":65},30,"ESTIMATED","INTERVENTIONAL",[68],"NA","The goal of this clinical trial is to learn more about intestinal regional oxygen saturation measurements made with near-infrared spectroscopy and bladder pressure measurements in infants without risk of intraabdominal hypertension. The main question it aims to answer is if - in comparison to bladder pressure - the regional intestinal oxygen saturation measured with near-infrared spectroscopy is stable in the muscle-relaxed, intubated patients and the awake and non-sedated patient.\n\nIn case of participation the bladder pressure and the regional intestinal oxygen saturation (measured with near-infrared spectroscopy) will each be measured once intraoperatively and once postoperatively. Patients included in this study will be undergoing an operation which necessitates muscle-relaxation, as well as an indwelling urinary catheter during the operation and for a short-time thereafter for other reasons than this study.",[71,72],"Intraabdominal Hypertension","Abdominal Compartment Syndrome",[74,75,76],"Near infra-red spectroscopy","Bladder pressure","Intraabdominal pressure","2024-04-24",{"date":79,"type":80},"2024-04-25","ACTUAL",{"date":82,"type":65},"2024-05-01",{"date":84,"type":65},"2026-06-30",{"name":5,"class":6},1]