Comparison of Bladder Pressure Versus Regional Intestinal Tissue Oxygenation in Infants (BPvsNIRS)

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.

Study Overview

• Status: Recruiting
• Conditions: Abdominal Compartment Syndrome; Intraabdominal Hypertension
• Intervention / Treatment: Diagnostic test: Near infrared-spectroscopy

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hannah R Neeser, MD; Phone Number: +41442667111; Email: hannah.neeser@kispi.uzh.ch
• Study Contact Backup: Name: Ueli Moehrlen, MD; Phone Number: +41442667111; Email: ueli.moehrlen@kispi.uzh.ch

Study Locations

• Switzerland
  • Zurich
    • Zürich, Zurich, Switzerland, 8032
      • Recruiting
      • University Children's Hospital Zurich
      • Contact: Hannah R Neeser; Phone Number: +41442667111; Email: hannah.neeser@kispi.uzh.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single Arm	Diagnostic test: Near 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Children's Hospital, Zurich
• Investigators: Principal Investigator: Hannah R Neeser, MD, University Children's Hospital of Zurich

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: May 15, 2023
• First Submitted That Met QC Criteria: July 24, 2023
• First Posted (Actual): August 2, 2023

Study Record Updates

• Last Update Posted (Actual): April 25, 2024
• Last Update Submitted That Met QC Criteria: April 24, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Intraabdominal pressure; Near infra-red spectroscopy; Bladder pressure
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Musculoskeletal Diseases; Muscular Diseases; Compartment Syndromes; Intra-Abdominal Hypertension
• Other Study ID Numbers: 1002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No