跳至主要内容
临床试验/NCT02302300
NCT02302300已完成不适用

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.

University Hospital, Brest2 个研究点 分布在 1 个国家目标入组 216 人开始时间: 2014年5月27日最近更新:
适应症
干预措施

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

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

Experimental

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

No Intervention

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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