Contribution of Mechanical Insufflation-Exsufflation in Preventing Respiratory Failure Post Extubation in Patient With Critical Care Neuromyopathy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 123
- 试验地点
- 2
- 主要终点
- Incidence of respiratory failure after extubation
研究概览
简要总结
Respiratory failure after extubation is a relevant consequence of poor airway clearance due to respiratory muscle weakness and respiratory failure after extubation and reintubation is associated with increased morbidity and mortality.
the study will evaluate the contribution of Mechanical Insufflation-Exsufflation (MI-E) in Preventing Respiratory Failure After Extubation as compared manually assisted coughing
详细描述
Critical Care Neuromyopathy (CCN) occur in 25% of patient in Intensive Care Unit (ICU). Respiratory failure after extubation is a relevant consequences of poor airway clearance due to respiratory muscle weakness. Respiratory failure is a major cause for reintubation which increase severity of illness, this is an independent risk factor for nosocomial pneumonia, increased hospital stay and mortality. Currently, respiratory physiotherapy includes, manual expiration assist often associated with nasotracheal aspiration. Despite of this care, respiratory failure occur in 30% of patients within 48 after planned extubation. MI-E has been evaluated for neuromuscular disease patient, and increase peak cough flow and the airway clearance. So the beneficials effects of MI-E should be confirmed in a trial in this specific population.
We planned to conduct a study evaluating the efficacy of MI-E in the prevention of extubation failure and mortality in these patients. If no signs of respiratory failure appeared after 120 min of a spontaneous breathing trial, patients will be extubated and randomly allocated after extubation to MI-E group or control group. The clinical follow-up will be as follow: the incidence of extubation failure, the reintubation, the ICU or 28-day survival,90-day survival, ICU length of stay.
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
- •Male or female patient aged ≥ 18 years.
- •Patient admitted in participant ICU.
- •Patient intubated for 48 hours at least.
- •Patient presenting an ICU acquired neuromuscular disorders.
排除标准
- •Respiratory or haemodynamic instability.
- •Patient having a contraindication to use face mask (Recent facial surgery, severe craniofacial trauma,...) gastroesophageal surgery.
- •Severe ventricular rhythm disorders.
- •Patient with tracheotomy.
- •Uncontrollable vomiting.
- •Severe sepsis.
- •Upper airway disorders.
- •Upper gastrointestinal bleeding.
- •Any decision to limit therapeutic effort in the ICU.
- •Patient with limit therapeutic effort in the ICU with unsuccessful spontaneous respiratory trial.
研究组 & 干预措施
MI-E plus manually assisted coughing
干预措施: MI-E plus manually assisted coughing (Procedure)
Manually assisted coughing only
干预措施: manually assisted coughing (Procedure)
结局指标
主要结局
Incidence of respiratory failure after extubation
时间窗: 48h post extubation (48h after inclusion)
次要结局
- the average time of hospitalization in the intensive care unit(End of intensive care or day 28 after inclusion)
- the incidence of nasotracheal suction(End of intensive care or day 28 after inclusion)
- 90 days survival(90 days after inclusion)
- the number of additional physiotherapy sessions(End of intensive care or day 28 after inclusion)
- the increase in peak cough flow(End of intensive care or day 28 after inclusion)
- the ICU mortality or 28-day survival(28 days after inclusion)
- the incidence of reintubation(End of intensive care or day 28 after inclusion)