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

July 28, 2026 updated by: University Children's Hospital, Zurich

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

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • Canton of Zurich
      • Zurich, Canton of Zurich, Switzerland, 8032
        • University Children's Hospital Zurich

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: intraoperative measurements taken within the first 10 minutes after anaesthesia induction
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
Time Frame: postoperative measurements taken within the first three postoperative days
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
Time Frame: taken once intraoperatively within the first 10 minutes after anaesthesia induction and once postoperatively within the first three postoperative days
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

This is where you will find people and organizations involved with this study.

Sponsor

University Children's Hospital, Zurich

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 17, 2024

Primary Completion (Actual)

July 23, 2026

Study Completion (Actual)

July 25, 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)

July 29, 2026

Last Update Submitted That Met QC Criteria

July 28, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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