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

University of Zurich (UZH)

Status: Enrolling

Conditions: Intraabdominal Hypertension; Abdominal Compartment Syndrome

Treatments: Diagnostic Test: Near infrared-spectroscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT05971264

1002

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: Under 12 months old

Volunteers: Accepts 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Single Arm

Experimental group

Treatment:

Diagnostic Test: Near infrared-spectroscopy