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临床试验/NCT01416519
NCT01416519已完成不适用

Incentive Spirometry Decreases Respiratory Complications After Myocardial Revascularization

Santa Casa de Votuporanga2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2011年9月1日最近更新:
适应症

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

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

发起方
Santa Casa de Votuporanga
申办方类型
Other
责任方
Principal Investigator
主要研究者

Marcos Aurelio Barboza de Oliveira

M.D.

Santa Casa de Votuporanga

研究点 (2)

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