Actively Recruiting
Comparison of Bladder Pressure Versus Regional Intestinal Tissue Oxygenation in Infants
Led by University Children's Hospital, Zurich · Updated on 2024-04-25
30
Participants Needed
1
Research Sites
25 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying infants 12 months or younger undergoing surgeries such as laparoscopic pyeloplasty, minimal PSARP, or lateral thoracotomy for esophageal atresia correction to better understand intestinal regional oxygen saturation compared to bladder pressure. The study aims to determine if near-infrared spectroscopy measurements of intestinal oxygen saturation remain stable during muscle-relaxed, intubated states and in awake, non-sedated patients. This investigation focuses on infants without risk of intraabdominal hypertension or abdominal compartment syndrome. The study involves measuring bladder pressure and regional intestinal oxygen saturation with near-infrared spectroscopy twice for each participant: once during surgery within the first 10 minutes after anesthesia induction when the patient is muscle-relaxed and intubated, and once postoperatively during the first three days when the infant is awake and non-sedated. An indwelling urinary catheter is used during and shortly after surgery for bladder pressure measurement. This is a single-arm interventional diagnostic study conducted by the University Children's Hospital, Zurich. Participants will undergo surgery as planned and have these measurements taken intraoperatively and postoperatively. The study team will assess intestinal oxygen saturation stability and bladder pressure values at these times. Measurements are taken during anesthesia and in the recovery period to compare the two methods. Participation lasts through the immediate operative and postoperative periods, with no long-term follow-up mentioned.
CONDITIONS
Brief Title
Comparison of Bladder Pressure Versus Regional Intestinal Tissue Oxygenation in Infants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Prepped and consented for laparoscopic pyeloplasty, minimal PSARP with perineal or vestibular fistula, or lateral thoracotomy for esophageal atresia correction
- Age 12 months old or less at the time of operation
- Legal custodian provides consent
You will not qualify if you...
- Anterior abdominal wall thickness greater than 12 mm on preoperative MRI if available
- Planned additional intestinal surgeries or non-standard pyeloplasty, such as pyeloplasty with nephrostoma
- Planned laparoscopic pyeloplasty patients with pathological intraoperative urine sample results
- Patients with esophageal atresia who experience pulmonary decompensation requiring urgent surgery for fistula clipping
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 days post-surgery
Participants undergo measurements of regional intestinal oxygen saturation and bladder pressure during surgery and in the first three postoperative days.
1 intraoperative measurement and up to 3 postoperative assessments
Trial Site Locations
Total: 1 location
1
University Children's Hospital Zurich
Zurich, Canton of Zurich, Switzerland, 8032
Actively Recruiting
Research Team
H
Hannah R Neeser, MD
U
Ueli Moehrlen, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here