Effect of PEP on Oxygen Saturation and Carbon Dioxide After Abdominal Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Transcutaneous blood gas measurements: transcutaneous pCO2
研究概览
简要总结
Positive expiratory pressure( PEP) is routinely given to patients after surgery in order to improve lung function and oxygen saturation. There is, however, no evidence of effect on lung function, postoperative pneumonia or any other outcome (Guimarães MMF, Tyson AF). The investigators aim to test the immediate effects of PEP therapy on oxygen saturation and carbon dioxide after abdominal surgery. 80 patients will be investigated in RCT design with expiration using PEP or with expiration to a sham-PEP, a tube without resistance. At the end of the study we will also measure the effect of 10x3 deep breathing maneuvers without PEP or shamPEP. Primary outcome: Maximum and minimum levels of continuously measured oxygen saturation from pulse oximetry and transcutaneous carbon dioxide partial pressure during the trial.
详细描述
Background Hypoxia, reduced lung function and atelectais are common after abdominal surgery and can be hazardous in patients with chronic hypoxia. Positive expiratory pressure (PEP) therapy or incentive spirometry are routinely given to patients after abdominal surgery to counteract atelectasis and improve oxygen saturation. Patients are instructed by a physiotherapist to take deep inspiratory breaths and expire in a PEP-device or PEP bottle. The method is used routinely in Swedish hospital and the patient breathes against 10-15 cm water resistance. This is repeated 10x3 ie 10 deep breaths and exhalation towards PEP then rest, breath, rest and another 10 breaths. This procedure should be done once an hour after surgery. The idea is that this will widen alveoli and abolish atelectasis, thus increasing the oxygen uptake and reducing the risk of postoperative complications.
There is no evidence of effect of PEP and incentive spirometry on postoperative pulmonary complications after abdominal surgery (Guimarães MMF, Tyson AF). Nevertheless, PEP therapy is used in Sweden and internationally. There were no studies found reporting the immediate effect of PEP on continuous oxygen saturation and carbon dioxide partial pressure after surgery.
Aims
What effect does PEP have on oxygen saturation and carbon dioxide partial pressure? What is the effect of deep breathing maneuvers on oxygen saturation and carbon dioxide partial pressure?
Methods
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Care Provider, Outcomes Assessor)
盲法说明
tube without resistance is given to patients. Randomization order is given after the analysis.
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
- •Adult patients over 18 years of age who have undergone open or laparoscopic abdominal surgery.
- •Patients receiving postoperative PEP are asked the day after surgery if they want to participate in the study.
排除标准
- •Patients who cannot participate in using PEP or who do not agree to participate in the study.
结局指标
主要结局
Transcutaneous blood gas measurements: transcutaneous pCO2
时间窗: once, within one hour
transcutaneous pCO2
次要结局
- Pulse oximetry: oxygen saturation (SaO2)(once, within one hour)
- Lung function: PEF(once, within one hour)