Preoperative Inspiratory Muscle Training to Prevent Postoperative Pneumonia in Patients Undergoing Esophageal Resection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- UMC Utrecht
- 入组人数
- 245
- 试验地点
- 9
- 主要终点
- Pneumonia incidence
研究概览
简要总结
The PREPARE study is the first multicenter randomized controlled trial to evaluate the hypothesis that preoperative inspiratory muscle training leads to decreased pulmonary complications in patients undergoing esophageal resection.
详细描述
Rationale: Esophageal resection is associated with high incidences of postoperative pulmonary pneumonia. Numbers of 30% are reported in literature. Postoperative complications can result in prolonged hospital stay and increased health care costs. In cardiac surgery patients a reduction of postoperative pneumonia of 50% is reported as a result of a preoperative inspiratory muscle training program. While in some surgical centers IMT is already used in the preoperative phase in patients undergoing esophageal resection, the effect of this promising intervention has not yet been investigated in a randomised and controlled study design in large surgical populations other than cardiac surgery.
Primary objective: Investigate the effect of a preoperative inspiratory muscle training program on the incidence of postoperative pneumonia in patients undergoing esophageal resection.
Study design: Prospective multicenter randomised controlled clinical trial.
Main study parameters/endpoints: A significant reduction in incidence of postoperative pneumonia.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •(Cognitively) capable to understand and perform a preoperative IMT program
- •Surgery is scheduled at least 2 weeks after signing informed consent, since the patients need to be able to follow the intervention program for at least 2 weeks
- •Willing to sign the informed consent form
排除标准
- •Unable to communicate in Dutch language
- •Age < 18 years
- •Participating in a conflicting trial concerning esophageal resection
结局指标
主要结局
Pneumonia incidence
时间窗: Date of first pneumonia event. Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Pneumonia will be scored according to the Utrecht Pneumonia Scoring System.
次要结局
- Duration of mechanical ventilation(Time between intubation and first extubation (in general no more then 24 hours))
- Length of stay(Time between date of surgery and first discharge from ICU and first discharge from hospital (on average 14 days))
- Respiratory muscle function(At baseline, before surgery and 3, 6 and 9 days after surgery.)
- Pulmonary function(At baseline, before surgery and 3, 6 and 9 days after surgery.)
- Quality of life(At baseline and 4 weeks after surgery)
研究者
Frank JG Backx, MD PhD
Professor in Clinical Sports Medicine
UMC Utrecht