Comparison of Bladder Pressure Versus Regional Intestinal Tissue Oxygenation in Infants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 3
- 主要终点
- Intestinal rSpO2 measurements in muscle-relaxed, intubated patients
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- — 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Single Arm
干预措施: Near infrared-spectroscopy (Diagnostic Test)
结局指标
主要结局
Intestinal rSpO2 measurements in muscle-relaxed, intubated patients
时间窗: 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
时间窗: 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
次要结局
- Bladder pressure values(taken once intraoperatively within the first 10 minutes after anaesthesia induction and once postoperatively within the first three postoperative days)