Comparison of Bladder Pressure Versus Regional Intestinal Tissue Oxygenation in Infants

Study Overview
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Brief Summary
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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.

Official Title
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Comparison of Bladder Pressure Versus Regional Intestinal Tissue Oxygenation in Infants

Conditions
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Intraabdominal Hypertension, Abdominal Compartment Syndrome

Intervention / Treatment
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* Diagnostic Test: Near infrared-spectroscopy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 12 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single Arm<br> | Diagnostic Test: Near infrared-spectroscopy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intestinal rSpO2 measurements in muscle-relaxed, intubated patients | Our primary endpoint is the regional intestinal oxygen saturation (rSpO2) measurement (average of 5 measurements taken every 30 seconds within 2 minutes) in muscle-relaxed, intubated patients | intraoperative measurements taken within the first 10 minutes after anaesthesia induction | 
| Intestinal rSpO2 measurements in awake, non-sedated patients | Our primary endpoint is the regional intestinal oxygen saturation (rSpO2) measurements (average of 5 measurements taken every 30 seconds within 2 minutes) in awake, non-sedated patients | postoperative measurements taken within the first three postoperative days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bladder pressure values | Bladder pressure measurements measured under two different circumstances: once muscle-relaxed, intubated patients (i.e. under ideal circumstances for these measurements) and once in awake, non-sedated patients (less ideal circumstances). | taken once intraoperatively within the first 10 minutes after anaesthesia induction and once postoperatively within the first three postoperative days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Near infra-red spectroscopy, Bladder pressure, Intraabdominal pressure