Incentive Spirometry Decreases Respiratory Complications After Myocardial Revascularization
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Pulmonary complications
研究概览
简要总结
The objective of this study is to assess whether there is a difference between a care protocol with the use of incentive spirometry (Voldyne ®) and another with the application of NIV (non invasive ventilation with single-level pressure) as a form of therapy. The main focus of the study is to determine the incidence of pulmonary complications in each technique.
详细描述
Coronary artery bypass graft (CABG) can prolong and improve the quality of life of patients with ischemic coronary syndrome but with the advancement of medical intervention to eligible patients for this procedure are those with more comorbidities where conservation and palliative therapies have been tried without success.
Patients undergoing CABG often develop pulmonary complications such as atelectasis, restrictive ventilatory defect, decreased lung compliance, increased shunt and changes in gas exchange leading to probable hypoxemia. In an attempt to reduce the harmful effects and pulmonary complications arising from surgical procedures is instituted extensive physiotherapy program that tracks and monitors such patients from the preoperative to the postoperative immediate transfer to the ward and hospital discharge.
The objective of this study is to assess whether there is a difference between a care protocol with the use of incentive spirometry (Voldyne ®) and another with the application of NIV (non invasive ventilation with single-level pressure) as a form of therapy. The main focus of the study is to determine the incidence of pulmonary complications in each technique.
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
- None
入排标准
- 年龄范围
- 16 Years 至 —(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with indication for elective coronary artery bypass surgery who agreed to participate and signed the informed consent.
排除标准
- •patients with hemodynamic instability during the physiotherapy care
- •those who fail to complete all visits to the proposed protocol (whatever the reason)
- •extubation after 12 hours of ICU admission
- •major intraoperative hemorrhage
- •major bleeding in ICU requiring return to the operating room
- •cardiopulmonary arrest
- •contraindication to positive pressure (undrained pneumothorax, bronchopleural fistula, hemoptysis, vomiting) or intolerance to the method
结局指标
主要结局
Pulmonary complications
时间窗: 72 hours
Occurrence of pulmonary complications such as pneumonia, atelectasis or pleural effusion diagnosed with chest X-rays by ICU doctor.
次要结局
- Exams(72 hours)
研究者
Marcos Aurelio Barboza de Oliveira
M.D.
Santa Casa de Votuporanga
