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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Near infrared-spectroscopy | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | intraoperative measurements taken within the first 10 minutes after anaesthesia induction |
| 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 | postoperative measurements taken within the first three postoperative days |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | taken once intraoperatively within the first 10 minutes after anaesthesia induction and once postoperatively within the first three postoperative days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hannah R Neeser, MD | Contact | +41442667111 | hannah.neeser@kispi.uzh.ch | |
| Ueli Moehrlen, MD | Contact | +41442667111 | ueli.moehrlen@kispi.uzh.ch |
| Name | Affiliation | Role |
|---|---|---|
| Hannah R Neeser, MD | University Children's Hospital of Zurich | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Children's Hospital Zurich | Recruiting | Zurich | Canton of Zurich | 8032 | Switzerland |
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| ID | Term |
|---|---|
| D059325 | Intra-Abdominal Hypertension |
| ID | Term |
|---|---|
| D003161 | Compartment Syndromes |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D019265 | Spectroscopy, Near-Infrared |
| ID | Term |
|---|---|
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D013057 | Spectrum Analysis |
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|
| D002318 |
| Cardiovascular Diseases |
| D002623 |
| Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |