NCT05971264 Comparison of Bladder Pressure Versus Regional Intestinal Tissue Oxygenation in Infants
| NCT ID | NCT05971264 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Children's Hospital, Zurich |
| Condition | Intraabdominal Hypertension |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2024-05-01 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2024-05-01 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * Patients with esophageal atresia who experience pulmonary decompensation and need urgent surgery for fistula clipping
Contact & Investigator
Hannah R Neeser, MD
PRINCIPAL INVESTIGATOR
University Children's Hospital of Zurich
Frequently Asked Questions
Who can join the NCT05971264 clinical trial?
This trial is open to participants of all sexes, up to 12 Months, studying Intraabdominal Hypertension. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05971264 currently recruiting?
Yes, NCT05971264 is actively recruiting participants. Contact the research team at hannah.neeser@kispi.uzh.ch for enrollment information.
Where is the NCT05971264 trial being conducted?
This trial is being conducted at Zurich, Switzerland.
Who is sponsoring the NCT05971264 clinical trial?
NCT05971264 is sponsored by University Children's Hospital, Zurich. The principal investigator is Hannah R Neeser, MD at University Children's Hospital of Zurich. The trial plans to enroll 30 participants.