The Effectiveness of Inspiratory Muscle Training and Nasal High Flow Oxygen in Difficult Weaning of ICU Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 146
- 试验地点
- 2
- 主要终点
- Rate of weaning failure
研究概览
简要总结
The purpose of the present study is to investigate the effectiveness of inspiratory muscle training and nasal high flow oxygen in patients with difficult weaning and high-risk for re-intubation. The hypothesis of the study is that starting inspiratory muscle training once patients are awake and co-operative along with the application of nasal high flow oxygen immediately after extubation will have a beneficial effect in preventive re-intubation in these high-risk patients.
详细描述
20-30% of intubated patients are difficult to be weaned off the mechanical ventilation and have a prolonged ICU stay. It is well established that prolonged ICU stay is associated with reduced muscle strength, functional ability and quality of life.
Inspiratory muscle training (IMT) via a threshold device has been proposed as an effective exercise for minimizing the detrimental effect of mechanical ventilation in critical ill patients with prolonged weaning. Additionally, Nasal High Flow (NHF) oxygen has been proved to support efficiently either high or low-risk patients after extubation and thus preventing re-intubation.
A randomized intervention study was designed to assess the efficacy of combining IMT and NHF as therapeutic strategies for difficult weaning. Once patients with prognostic factors of difficult weaning are awake and co-operative they will be randomized to one of the two following study groups: 1) IMT and NHF group, 2) IMT and Venturi mask group. IMT will start as soon as the patient wakes up and is cooperative, ventilated with support settings. Each allocated oxygen delivery device will be applied immediately after extubation. IMT intervention will continue until patients' discharge from the ICU.
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
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>65 years,
- •BMI> 35kg/m2,
- •weak cough,
- •heart (i.e heart failure ) and lung comorbidities (i.e COPD),
- •hypercapnia during mechanical ventilation
- •> 72hours on mechanical ventilation
- •failed first spontaneous breathing trial
排除标准
- •Glasgow Coma scale (GCS)<13,
- •pre-existing neuromuscular disease or deformity of Spinal Cord,
- •terminal disease
- •hemodynamic instability with >0.1μg/kg/min noradrenaline
- •patients of immediately need of Non-invasive ventilation after extubation
结局指标
主要结局
Rate of weaning failure
时间窗: 48 hours after extubation
Rate of weaning failure in high-risk for reintubation patients
次要结局
- Functional ability(Within 24 hours after ICU discharge, within 24 hours before hospital discharge)
- Maximal Inspiratory Pressure(Within 2 hours after patient randomization, within 24 hours after extubation, within 24 hours after ICU discharge)
- Maximal Expiratory Pressure(Within 2 hours after patient randomization, within 24 hours after extubation, within 24 hours after ICU discharge)
- Endurance of respiratory muscles(Within 2 hours after patient randomization, within 24 hours after extubation , within 24 hours after ICU discharge)
- Muscle strenght(Within 2 hours after patient randomization, within 24 hours after ICU discharge, within 24 hours before hospital discharge)
- Short Form 36 Health Survey (SF-36) questionnaire(Within 24 hours before hospital discharge)
- Euro-Qol 5 Dimensions 5 Level of severity scale (Euro-Qol 5D-5L scale)(Within 24 hours before hospital discharge)
研究者
ISCHAKI ELENI
Consultant, ICU Department
Evangelismos Hospital