Comparison of Bladder Pressure Versus Regional Intestinal Tissue Oxygenation in Infants

NCT ID: NCT05971264

Last Updated: 2024-04-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-01

Study Completion Date

2026-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Intraabdominal Hypertension Abdominal Compartment Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Single Arm

Group Type EXPERIMENTAL

Near infrared-spectroscopy

Intervention Type 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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Maximum Eligible Age

12 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Children's Hospital, Zurich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hannah R Neeser, MD

Role: PRINCIPAL_INVESTIGATOR

University Children's Hospital of Zurich

Locations

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University Children's Hospital Zurich

Zurich, Canton of Zurich, Switzerland

Site Status RECRUITING

Countries

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Switzerland

Central Contacts

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Hannah R Neeser, MD

Role: CONTACT

+41442667111

Ueli Moehrlen, MD

Role: CONTACT

+41442667111

Facility Contacts

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Hannah R Neeser

Role: primary

+41442667111

Other Identifiers

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1002

Identifier Type: -

Identifier Source: org_study_id

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