Evaluation of Regional Ventilation Distribution in Patients Affected by Abdominal Sepsis After Emergent Laparotomy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Chest-wall compliance (Ccw) measured using respiratory parameters from the Ventilator
研究概览
简要总结
The goal of this clinical trial is to evaluate regional ventilation distribution in patients admitted to the intensive care unit after emergent laparotomy due to abdominal sepsis. The main question it aims to answer is:
• evaluate if patients admitted after an open abdomen strategy have a different regional ventilation distribution compared to patients in which abdomen is closed at the end of the procedure
Participants will undergo non-invasive monitoring (esophageal pressure and electrical impedance tomography) and an blood gas analysis samples.
Researchers will compare open abdomen group and closed abdomen group to see if the ventilation distribution pattern is different.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 and < 90 years
- •Admitted to the ICU after emergent laparotomy for abdominal sepsis
- •Acute respiratory failure
排除标准
- •Controindications to electrical impedance tomography monitoring
- •body mass index > 40 kg/m2
- •Haemodinamic instability
- •Pneumothorax - Pneumomediastinum
- •refusal to participate
结局指标
主要结局
Chest-wall compliance (Ccw) measured using respiratory parameters from the Ventilator
时间窗: Day 2
Different chest wall compliance between the two groups measured using the esophageal catheter. Chest wall compliance will be calculated using the data provided from the respiratory monitoring (i.e. esophageal balloon catheter).
次要结局
- Regional ventilation distribution measured using Electrical impedance tomography(Day 2)
- Mortality in the intensive care unit(Up to 28 days)
- Infection rate during ICU stay(Up to 28 days)
研究者
Savino Spadaro
Principal investigator
Università degli Studi di Ferrara