Abdominal Compartment Syndrome, Intraabdominal Hypertension
Conditions
Keywords
Near infra-red spectroscopy, Bladder pressure, Intraabdominal pressure
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.
Interventions
DIAGNOSTIC_TESTNear 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.
Sponsors
University Children's Hospital, Zurich
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 12 Months
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intestinal rSpO2 measurements in muscle-relaxed, intubated patients | intraoperative measurements taken within the first 10 minutes after anaesthesia induction | 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 | postoperative measurements taken within the first three postoperative days | 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
| Measure | Time frame | Description |
|---|---|---|
| Bladder pressure values | taken once intraoperatively within the first 10 minutes after anaesthesia induction and once postoperatively within the first three postoperative days | 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). |
Countries
Switzerland
Contacts
PRINCIPAL_INVESTIGATORHannah R Neeser, MD
University Children's Hospital of Zurich
Outcome results
None listed