RecruitingNot ApplicableNCT05971264

Comparison of Bladder Pressure Versus Regional Intestinal Tissue Oxygenation in Infants


Sponsor

University Children's Hospital, Zurich

Enrollment

30 participants

Start Date

May 1, 2024

Study Type

INTERVENTIONAL

Conditions

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

Max Age: 12 Months

Plain Language Summary

Simplified for easier understanding

This study is comparing two methods of monitoring abdominal pressure and blood flow in infants undergoing certain surgical procedures: traditional bladder pressure measurement versus a newer method that uses near-infrared light to measure oxygen levels in the intestinal tissue (called regional intestinal tissue oxygenation). The goal is to see which method better detects potential complications during surgery in very young patients. **You may be eligible if...** - Your infant is 12 months old or younger - They are scheduled for one of the following surgeries: laparoscopic kidney repair (pyeloplasty), a specific type of bowel surgery (minimal PSARP for anorectal malformation), or esophageal atresia repair through a small chest incision - You as the parent or legal guardian are willing and able to give consent **You may NOT be eligible if...** - The infant's abdominal wall is too thick for reliable monitoring on pre-operative imaging - Additional intestinal surgeries or non-standard procedures are planned - The infant has esophageal atresia and needs urgent emergency surgery - The infant's pre-operative urine sample shows abnormal results (for kidney surgery candidates) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTNear 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.


Locations(1)

University Children's Hospital Zurich

Zurich, Canton of Zurich, Switzerland

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NCT05971264


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