Comparison of Bladder Pressure Versus Regional Intestinal Tissue Oxygenation in Infants

NCT05971264 | Recruiting DMC

• 1 other identifier: 1002
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Intraabdominal Hypertension; Abdominal Compartment Syndrome

Keywords

Near infra-red spectroscopy; Bladder pressure; Intraabdominal pressure

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Bladder pressure values

  taken once intraoperatively within the first 10 minutes after anaesthesia induction and once postoperatively within the first three postoperative days

Study Arms (1)

Single Arm

EXPERIMENTAL

Diagnostic Test: Near infrared-spectroscopy

Interventions

Near infrared-spectroscopy DIAGNOSTIC_TEST

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.

Single Arm

Eligibility Criteria

• Age: Up to 12 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Children's Hospital, Zurich: lead

Study Sites (1)

University Children's Hospital Zurich

Zurich, Canton of Zurich, 8032, Switzerland

RECRUITING

MeSH Terms

Conditions

Intra-Abdominal Hypertension

Interventions

Spectroscopy, Near-Infrared

Condition Hierarchy (Ancestors)

Compartment Syndromes; Muscular Diseases; Musculoskeletal Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Hannah R Neeser, MD

  University Children's Hospital of Zurich

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hannah R Neeser, MD

CONTACT

+41442667111; hannah.neeser@kispi.uzh.ch

Ueli Moehrlen, MD

CONTACT

+41442667111; ueli.moehrlen@kispi.uzh.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2023
• First Posted: August 2, 2023
• Study Start: May 1, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: April 25, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)