Comparing bladder pressure and intestinal oxygen levels in infants
Comparison of Bladder Pressure Versus Regional Intestinal Tissue Oxygenation in Infants
This study is testing how bladder pressure and oxygen levels in the intestines compare in infants during and after certain surgeries to see if these measurements stay stable in different situations.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | N/A to 12 Months |
| Sex | All |
| Sponsor | University Children's Hospital, Zurich Academic / other |
| Locations | 1 site (Zurich, Canton of Zurich) |
| Trial ID | NCT05971264 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare bladder pressure measurements with regional intestinal oxygen saturation levels in infants undergoing specific surgical procedures. It will utilize near-infrared spectroscopy to assess oxygen levels in the intestines and measure bladder pressure both intraoperatively and postoperatively. The study focuses on infants who are muscle-relaxed and intubated, as well as those who are awake and non-sedated, to determine the stability of these measurements in different conditions.
Who should consider this trial
Good fit: Ideal candidates for this study are infants aged 12 months or younger who are scheduled for laparoscopic pyeloplasty or specific corrective surgeries.
Not a fit: Patients with significant abdominal wall thickness or those requiring additional intestinal surgeries may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve monitoring techniques for infants at risk of intraabdominal hypertension, leading to better patient outcomes.
How similar studies have performed: While this approach is innovative, similar studies have not been widely reported, indicating that this may be a novel investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Zurich, Canton of Zurich
- University Children's Hospital Zurich — Zurich, Canton of Zurich, Switzerland (Recruiting)
Study contacts
- Principal investigator: Hannah R Neeser, MD — University Children's Hospital of Zurich
- Study coordinator: Hannah R Neeser, MD
- Email: hannah.neeser@kispi.uzh.ch
- Phone: +41442667111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.