[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100513883":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":25,"locations":33,"responsibleParty":50,"collaborators":11,"id":52,"slug":11,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":58,"sex":59,"minAge":11,"maxAge":60,"enrollmentInfo":61,"targetDuration":11,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":71,"overallStatus":36,"whyStopped":11,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"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,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"University Children's Hospital Zurich","RECRUITING","Zurich","Canton of Zurich","8032","Switzerland",{"type":42,"coordinates":43},"Point",[44,45],8.55,47.36667,{"lat":45,"lon":44},[48],{"name":49,"role":27,"phone":28,"phoneExt":11,"email":29},"Hannah R Neeser",{"type":51,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","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":62,"type":63},30,"ESTIMATED","INTERVENTIONAL",[66],"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.",[69,70],"Intraabdominal Hypertension","Abdominal Compartment Syndrome",[72,73,74],"Near infra-red spectroscopy","Bladder pressure","Intraabdominal pressure","2024-04-24",{"date":77,"type":78},"2024-04-25","ACTUAL",{"date":80,"type":63},"2024-05-01",{"date":82,"type":63},"2026-06-30",{"name":5,"class":6},1]