Study of the Combined Influence of Sepsis and Mechanical Ventilation on the Human Diaphragm
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Assessment of atrophy of the myofibers of the human diaphragm
研究概览
简要总结
The aim of this study is to study the combined impact of mechanical ventilation and sepsis on the human diaphragm in order to establish the neutral, protective or destructive character of mechanical ventilation by studying the diameter of the fibers, activation of proteolytic systems, inhibition of protein synthesis, tissue inflammation as well as contractile function.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient at least 18 years of age, male or female requiring abdominal or thoracic surgery or multi-organ sampling;
- •Affiliated to a social security or similar system;
- •Not subject to legal protection;
- •Having given consent to participate in the study (or consent from the trusted person)
- •Control group (C): non-septic mesocolic programmed abdominal or thoracic surgery: gastrectomy, esophagectomy, pancreatectomy, hepatectomy
- •Sepsis group (S): Abdominal or thoracic surgery in a septic context (peritonitis, mediastinitis, pleural abscess)
- •Group Mechanical Ventilation (MV): Patient in brain death for which a multi organ sample is planned
- •Mechanical Ventilation + Sepsis (S-MV) group: Patient under controlled mechanical ventilation to undergo abdominal or thoracic surgery in a septic context (peritonitis, mediastinitis, pleural abscess)
排除标准
- •Pregnant woman (diagnosis of interrogation)
- •severe and / or unbalanced chronic respiratory disease; severe malnutrition
- •Long-term corticosteroids> 5mg / day for more than 1 month
- •surgery by laparoscopic
- •Control group: Sepsis, preoperative controlled mechanical ventilation and preoperative hemodynamic instability
- •Mechanical Ventilation Group: Sepsis, duration of controlled mechanical ventilation <24 hours or> 7 days
- •Sepsis Group: Preoperatively controlled mechanical ventilation
- •Mechanical Ventilation - Sepsis Group: duration of controlled mechanical ventilation <24 hours or> 7 days
研究组 & 干预措施
control group
non-septic mesocolic programmed abdominal or thoracic surgery: gastrectomy, esophagectomy, pancreatectomy, hepatectomy
干预措施: surgery (Procedure)
sepsis group
Abdominal or thoracic surgery in a septic context (peritonitis, mediastinitis, pleural abscess)
干预措施: surgery (Procedure)
mechanical ventilation group
Patient in brain death for whom a multi-organ sampling is planned
干预措施: multi-organ sampling (Procedure)
mechanical ventilation - sepsis group
Patient under controlled mechanical ventilation to undergo abdominal or thoracic surgery in a septic context (peritonitis, mediastinitis, pleural abscess)
干预措施: surgery (Procedure)
结局指标
主要结局
Assessment of atrophy of the myofibers of the human diaphragm
时间窗: day 0 (day of the surgery)
Atrophy of the myofibers will be assessed by comparison of the cross sectional area of the three different types of myofibers between the sepsis-mechanical ventilation group and the sepsis group, the ventilation group and the control group
次要结局
未报告次要终点