Clinical trial NCT05971264: Comparison of Bladder Pressure Versus Regional Intestinal Tissue Oxygenation in Infants
Official title: Comparison of Bladder Pressure Versus Regional Intestinal Tissue Oxygenation in Infants
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Intraabdominal Hypertension
Abdominal Compartment Syndrome
Keywords: Near infra-red spectroscopy
Bladder pressure
Intraabdominal pressure
Lead sponsor: University Children's Hospital, Zurich
Sponsor class: OTHER
First posted: 2023-08-02
Enrollment: 30
Sex: ALL
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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

Primary outcomes:
measure: Intestinal rSpO2 measurements in muscle-relaxed, intubated patients
timeFrame: intraoperative measurements taken within the first 10 minutes after anaesthesia induction
measure: Intestinal rSpO2 measurements in awake, non-sedated patients
timeFrame: postoperative measurements taken within the first three postoperative days
Secondary outcomes:
measure: Bladder pressure values
timeFrame: taken once intraoperatively within the first 10 minutes after anaesthesia induction and once postoperatively within the first three postoperative days
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: University Children's Hospital Zurich
state: Zurich
Study officials:
affiliation: University Children's Hospital of Zurich
name: Hannah R Neeser, MD
role: PRINCIPAL_INVESTIGATOR
References: