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

Primary Purpose

Intraabdominal Hypertension, Abdominal Compartment Syndrome

Status
Not yet recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Near infrared-spectroscopy
Sponsored by
University Children's Hospital, Zurich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Intraabdominal Hypertension focused on measuring Near infra-red spectroscopy, Bladder pressure, Intraabdominal pressure

Eligibility Criteria

undefined - 12 Months (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University Children's Hospital Zurich

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single Arm

Arm Description

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

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).

Full Information

First Posted
May 15, 2023
Last Updated
July 24, 2023
Sponsor
University Children's Hospital, Zurich
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1. Study Identification

Unique Protocol Identification Number
NCT05971264
Brief Title
Comparison of Bladder Pressure Versus Regional Intestinal Tissue Oxygenation in Infants
Acronym
BPvsNIRS
Official Title
Comparison of Bladder Pressure Versus Regional Intestinal Tissue Oxygenation in Infants
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 1, 2024 (Anticipated)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
June 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Children's Hospital, Zurich

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intraabdominal Hypertension, Abdominal Compartment Syndrome
Keywords
Near infra-red spectroscopy, Bladder pressure, Intraabdominal pressure

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Single Arm
Arm Type
Experimental
Intervention Type
Diagnostic Test
Intervention Name(s)
Near infrared-spectroscopy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Intestinal rSpO2 measurements in muscle-relaxed, intubated patients
Description
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
Time Frame
intraoperative measurements taken within the first 10 minutes after anaesthesia induction
Title
Intestinal rSpO2 measurements in awake, non-sedated patients
Description
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
Time Frame
postoperative measurements taken within the first three postoperative days
Secondary Outcome Measure Information:
Title
Bladder pressure values
Description
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).
Time Frame
taken once intraoperatively within the first 10 minutes after anaesthesia induction and once postoperatively within the first three postoperative days

10. Eligibility

Sex
All
Maximum Age & Unit of Time
12 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hannah R Neeser, MD
Phone
+41442667111
Email
hannah.neeser@kispi.uzh.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Ueli Moehrlen, MD
Phone
+41442667111
Email
ueli.moehrlen@kispi.uzh.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hannah R Neeser, MD
Organizational Affiliation
University Children's Hospital of Zurich
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Children's Hospital Zurich
City
Zürich
State/Province
Zurich
ZIP/Postal Code
8032
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No

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Comparison of Bladder Pressure Versus Regional Intestinal Tissue Oxygenation in Infants

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