RecruitingNot Applicable

Comparison of Bladder Pressure Versus Regional Intestinal Tissue Oxygenation in Infants

Switzerland30 participantsStarted 2024-05-01

Plain-language 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.

Who can participate

Age range

12 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Intestinal rSpO2 measurements in muscle-relaxed, intubated patients

Timeframe: intraoperative measurements taken within the first 10 minutes after anaesthesia induction

Intestinal rSpO2 measurements in awake, non-sedated patients

Timeframe: postoperative measurements taken within the first three postoperative days

Trial details

NCT IDNCT05971264

SponsorUniversity Children's Hospital, Zurich

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-31

Contact for this trial

Hannah R Neeser, MD

+41442667111 hannah.neeser@kispi.uzh.ch

View on ClinicalTrials.gov More Intraabdominal Hypertension trials