Effects of Prone Position After Major Abdominal Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Number of participants with treatment-related adverse events of postoperative lung and abdominal complications incl a CT scan for objective measurement
研究概览
简要总结
Evaluation of postoperative prone position after major abdominal surgery. A randomized clinical trial of 100+100 patients and further add a voice/speech/singing protocol.
详细描述
Evaluation of postoperative prone position after major abdominal surgery. A randomized clinical trial of 100+100 patients and further add a voice/speech/singing protocol.
The patients will be randomized to the standard ERAS-protocol, enhanced recovery after surgery with or without adding periods of prone position after surgery.
They will be followed by protocol both as a momentum effect (experimental study) on POD 2-5 and also POD 7.
The aim is evaluation of prone position in order to improve the ventilation and hopefully diminish the risk of for example pneumonia and thromboembolism.
Inclusion criteria Patients referred to the Department of Surgery for major abdominal surgery of the esophagus, gastric- or pancreas surgery aim to cure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients eligable for abdominal surgery aim to cure with:
- •Inclusion Criteria:
- •- malignancy of the esophagus, gastric- or pancreas
排除标准
- •.not able to understand Swedish in writing or speaking
- •- preoperatively unable to perform a prone position
结局指标
主要结局
Number of participants with treatment-related adverse events of postoperative lung and abdominal complications incl a CT scan for objective measurement
时间窗: through study completion, an average of 1 year
Adverse events like pneumonia, lungembolism, lungempyema, interventions pankreatitis
Oxygen saturation measurement postoperatively
时间窗: an average of (POD) Postoperative day 2-7
Measurement during sitting position
Number of participants with treatment-related adverse events of postoperative lung and abdominal complications
时间窗: through study completion, an average of 1 year
Pneumonia, Lung embolism, Empyema of the lung, pankreatitis
次要结局
- Number of participants needing intervention(through study completion, an average of 1 year)
- Number of participants with treatment-related diminished lung volumes(through study completion, an average of 1 year)
- Number of days of Hospital care(through study completion, an average of 1 year)
研究者
Cecilia Engström-Mattisson
MD PhD Associated Professor
Vastra Gotaland Region