Interest of the Not Invasive Ventilation Used in Meadow and Post-operative of Cardiac Surgery, in Disease Prevention of the Cardiac and/or Lung Complications at the Patients at Risk.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 216
- 试验地点
- 2
- 主要终点
- Appearance of cardio-pulmonary complications in postoperative cardiac surgery
研究概览
简要总结
After cardiac surgery, many complications can arise, in particular at the cardiac and lung level and it is true especially as the patient is with comorbidity. A patient will be considered at risk of a cardiac surgery if risk factors are present in preoperative (obesity, Chronic obstructive pulmonary disease (COPD), etc...). The non-invasive ventilation (NIV)developed these last years in the treatment of acute cardiac insufficiency and the hypercapnic COPD exacerbations; its use is more and more envisaged in cardio-thoracic and abdominal surgery services.
Studies showed that the NIV allowed an improvement of the oxygenation, the lung volumes and a decrease of ventilation work. According to these observations, the preventive NIV could reduce the incidence of appearance of the lung and/or cardiac complications at the patients to risk. we estimate 40 to 50%of cardiac surgery patients at a high risk level and we expect to obtain a benefit with this particular population. If we meet our goal (a significant difference in terms of morbi-mortality with the preventive NIV versus classical care), we expect the systematisation of this procedure to all cardiac surgery high risk patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Every patient of more than 18 years, programmed for a cardiac surgery ( valve replacement, coronary bypass, aortic surgery) in the service of "Chirurgie Cardio-Thoracique et Vasculaire" (CCTV) of the CHRU of Brest
- •and obesity (BMI > 30 kg/m2
- •and/or COPD (stages 1-2 and 3, classification GOLD)
- •and/or restrictive syndrome (CPT 80 %)
- •and/or cardiac insufficiency (FEVG 55 %)
- •and/or syndrome of obesity-hypoventilation not requiring an equipment
- •and/or Syndrome of sleep apnea not requiring an equipment
排除标准
- •Patients having a contraindication absolved from the NIV
- •Patients carrier of a neuro-muscular disease
- •Patients carrier of a syndrome of sleep apnea and/or COPD, and sailed
- •Hypercapnic patients (with a limit value of PaCO2 > 55 mm Hg)
- •Unaffiliated patients to a social diet of safety
- •Patients under guardianship or under guardianship
- •Patient who can not follow the NIV program as well as the patients of whom the consent was not collected.
研究组 & 干预措施
Manufacturer STELLAR 150
5 days of non-invasive ventilation at two levels of pressure from it pre-operative, followed by 5 days in post-operative.
干预措施: Manufacturer STELLAR 150 (Device)
Control Group
Standard preparation
结局指标
主要结局
Appearance of cardio-pulmonary complications in postoperative cardiac surgery
时间窗: 1 month
Appearance of cardio-pulmonary complications in postoperative cardiac surgery among the complications listed below: * Atelectasis * Acute respiratory insufficiency * Acute cardiac insufficiency * Pneumothorax * Arrhythmia * Myocardial infarction * Cardiac tamponade
次要结局
- Determine postoperative mortality; length of stay in intensive care, length of stay in the service of CCTV(1 and 3 month)
