Effects of Variable Tidal Volumes During Open Abdominal Surgery on Lung Function and Systemic Inflammation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Forced vital capacity
研究概览
简要总结
Variable ventilation has been shown to improve lung function and reduce lung damage as well as inflammation in different models of the acute respiratory distress syndrome. Also, variable ventilation is able to recruit lungs. The present study will investigate whether variable as compared to non-variable ventilation improves post-operative lung function and reduces systemic inflammation in patients submitted to open abdominal surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •elective open abdominal surgery
- •ASA classification 2-3
- •age between 18 und 85 yrs
- •expected duration of surgery > 3 h
- •expected extubation in the operation room
- •written informed consent
排除标准
- •chronic lung disease (except to COPD stadium I and II, and asthma)
- •Body Mass Index (BMI) > 40
- •allergy to one of the drugs to be used for general anesthesia
- •participation in another interventional trial within 4 weeks before enrollment
- •addiction or any other disease that may interfere with the capacity of giving informed consent
- •pregnant or breastfeeding women
- •women in reproductive age, except to those who fulfill one of the following:
- •post-menopause (12 months natural amenorrhoea, or 6 months amenorrhoea and serum FSH > 40 mlU/ml
- •post-operative (6 weeks after two-sided ovariectomy)
- •routine and correct use of anticonceptional methods with failure rate < 1 % per year
- •sexually not active
- •vasectomy of the partner
- •indication of low compliance with the protocol
- •contraindication for MRI examination
研究组 & 干预措施
Variable Ventilation
Variable tidal volumes with mean at 8 mL/kg of predicted body weight
干预措施: Variable Ventilation (Other)
Non-variable Ventilation
Conventional mechanical ventilation with tidal volume 8 mL/kg of predicted body weight
结局指标
主要结局
Forced vital capacity
时间窗: Preoperative until 5th postoperative day
Forced vital capacity is assessed on the first postoperative day
次要结局
- Postoperative pulmonary complications(Preoperative until discharge from hospital)
- Peak expiratory flow(Preoperative until 5th postoperative day)
- Distribution of ventilation(Preoperative until 5th postoperative day)
- Arterial partial CO2 pressure(Preoperative until 5th postoperative day)
- Forced expiratory volume after 1 sec(Preoperative until 5th postoperative day)
- PaO2/FIO2(Preoperative until 5th postoperative day)
- Atelectasis(Preoperative until 5th postoperative day)
- Inflammation markers(Preoperative until 5th postoperative day)