Comparison of Bladder Pressure Versus Regional Intestinal Tissue Oxygenation in Infants
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 12
SponsorUniversity Children's Hospital, Zurich
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Treatments tested in this trial
- Near infrared-spectroscopy
Treatment groups
30 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov