NCT05971264Completed
Comparison of Bladder Pressure Versus Regional Intestinal Tissue Oxygenation in Infants
Source: ClinicalTrials.gov · Last updated 29 Jul 2026
Brief summary (registry, in English)
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. In 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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 30 (actual)
- First submitted
- 15 May 2023
- Start date
- 17 May 2024
- Primary completion date
- 23 Jul 2026
- Lead sponsor
- University Children's Hospital, Zurich
- Diseases
- High blood pressure
- NCT number
- NCT05971264
What you commit to
- Study type: Interventional
- Participants enrolled: 30
- From 17 May 2024 to the primary completion date, 23 Jul 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Patients with esophageal atresia who experience pulmonary decompensation and need urgent surgery for fistula clipping
Other
- Anterior abdominal wall thickness greater than 12 mm measured on preoperative MRI imaging if available
- Patients planned for additional intestinal surgeries or non-standard pyeloplasty, e.g. pyeloplasty with nephrostoma
- Patients planned for laparoscopic pyeloplasty whose intraoperative urine sample shows pathological results
Who the study is looking for
- Prepped and consented for laparoscopic pyeloplasty or minimal PSARP with perineal or vestibular fistula or lateral thoracotomy for the correction of esophageal atresia
- Age of 12 months old or less at operation
- Legal custodian gives consent
Age in the registry: - to 12 months · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Children's Hospital Zurich Coordinator of this site? Confirm its status | Zurich | Switzerland | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.