Use of Mechanical Insufflator-exsufflator in Patients After Video-assisted Thoracoscopic Operations With One-lung Ventilation on Postoperative Pulmonary Complications: a Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Sputum volume 24 hours after tracheal extubation
研究概览
简要总结
Postoperative pulmonary complications (PPC) are a common problem in patients undergoing surgery using one-lung invasive ventilation. Major pulmonary complications such as atelectasis, bronchospasm, and pneumonia can lead to respiratory failure. PPC are the main cause of mortality in the postoperative period in patients after thoracic surgery. The study aimed to compare the effectiveness of using a mechanical insufflator-exsufflator after video-assisted thoracoscopic surgery using one-lung ventilation to reduce postoperative pulmonary complications as compared to standard therapy.
详细描述
Postoperative pulmonary complications (PPC) are a common problem in patients undergoing surgery using one-lung invasive ventilation. Major pulmonary complications such as atelectasis, bronchospasm, and pneumonia can lead to respiratory failure. PPC are the main cause of mortality in the postoperative period in patients after thoracic surgery. The incidence of PPC ranges from 5% to 80%. Patients undergoing thoracic surgery are usually at high risk. Most often these are elderly people with concomitant diseases. Most of these patients are smokers, have occupational exposures, and are therefore at even greater risk of developing pulmonary complications. Part of their problem is due to poor baseline pulmonary function. Improving mucus production in the postoperative period using a mechanical insufflator-exsufflator may help reduce the incidence of complications.
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Video-assisted thoracoscopic surgery using one-lung ventilation
- •Age 18-65 years Forced expiratory volume in one second (FEV1) 60% of predicted or more
- •Absence of pronounced bronchial secretion before surgery
- •Written informed consent.
排除标准
- •Age less than 18 and more than 65 years
- •Presence of pneumothorax 6 hours after surgery on radiography
- •Pulmonary hemorrhage of any intensity
- •Unstable hemodynamics
- •Forced expiratory volume in one second (FEV1) is less than 60% of predicted during preoperative examination
- •The scope of the operation is more than a lobectomy
- •Bilateral and combined operations
- •Mechanical ventilation after surgery for more than 6 hours
- •Anesthesia risk according to American Society of Anesthesiologists (ASA) 4 and 5 points
研究组 & 干预措施
Standard care
Standard postoperative care without mechanical insufflator-exsufflator.
Mechanical insufflator-exsufflator
Standard postoperative care plus mechanical insufflator-exsufflator during the first postoperative day.
干预措施: Mechanical insufflator-exsufflator (Device)
结局指标
主要结局
Sputum volume 24 hours after tracheal extubation
时间窗: On 24 hour after operation
Sputum volume 24 hours after tracheal extubation
Peripheral oxygen saturation level (SpO2) when breathing atmospheric air 24 hours after tracheal extubation
时间窗: On 24 hour after operation
Peripheral oxygen saturation level (SpO2) when breathing atmospheric air 24 hours after tracheal extubation
Peak expiratory flow (PEF) 48 hours after surgery
时间窗: On 48 hour after operation
Peak expiratory flow (PEF) 48 hours after surgery,
Peripheral oxygen saturation level (SpO2) when breathing atmospheric air 6 hours after tracheal extubation
时间窗: On 6 hour after operation
Peripheral oxygen saturation level (SpO2) when breathing atmospheric air 6 hours after tracheal extubation
The volume of atelectasis on chest computed tomography 36-48 hours after tracheal extubation
时间窗: On 36-48 hour after operation
The volume of atelectasis on chest computed tomography 36-48 hours after tracheal extubation
次要结局
- Postoperative pulmonary complications(Day 7 after operation)
- Pain according to visual analogue scale (VAS) of pain 24 hours after tracheal extubation(On 24 hour after operation)
- Dyspnea according to visual analogue scale (VAS) of dyspnea 6 hours after tracheal extubation(On 6 hour after operation)
- Pain according to visual analogue scale (VAS) of pain 6 hours after tracheal extubation(On 6 hour after operation)
- Dyspnea according to visual analogue scale (VAS) of dyspnea 24 hours after tracheal extubation(On 24 hour after operation)