Impact of Global Physiotherapy on Acute Respiratory Failure Within 7 Days After Extubation in Intensive Care Unit Patients With High Risk of Extubation Failure.
概览
- 阶段
- 不适用
- 干预措施
- Experimental
- 疾病 / 适应症
- Acute Respiratory Failure
- 发起方
- University Hospital, Bordeaux
- 入组人数
- 256
- 试验地点
- 1
- 主要终点
- Rate of acute respiratory failure
- 状态
- 招募中
- 最后更新
- 3个月前
概览
简要总结
This study aims to compare care provided by physiotherapists, combining respiratory care and early rehabilitation in intensive care unit, with standard care on the rate of acute respiratory failure within 7 days after extubation, in patients with high risk of extubation failure.
详细描述
The extubation failure rate is 15% on average in intensive care units, but can reach 30% within 48 hours after extubation in high risk patients. Their characteristics are : age \> 65 years, respiratory disease, body mass index \> 30 kg / m², intubation for more than 7 days, first extubation failure, and patient with ineffective cough associated with bronchial obstruction. The main reason for reintubation in these patients is acute respiratory failure with an ineffective cough, a bronchial obstruction, and neuromyopathy. On these three components, the physiotherapist can apply specific techniques. Even though scientific literature recommends the presence of a physiotherapist before, during and after extubation in patients intubated for more than 48 hours, the benefits of physiotherapy in this context remains poorly explored. The main objective of this study is to compare the rate of acute respiratory failure within 7 days post-extubation in high-risk intensive care patients. The secondary objectives are to compare the ROX index, the reintubation rate for acute respiratory failure within 7 days after extubation, the rate of pneumonia at 7 days, time spent on respiratory and mobilization care.
研究者
入排标准
入选标准
- •Patients with spontaneous ventilation weaning test.
- •Consent form signed by the person support.
排除标准
- •Patients with a self-extubation,
- •Patients with a tracheostomy,
- •Patients with acute respiratory failure for acute lung edema (OAP),
- •Patients with decision to limit or stop Active Therapeutics (LATA).
研究组 & 干预措施
experimental
干预措施: Experimental
control
干预措施: Control
结局指标
主要结局
Rate of acute respiratory failure
时间窗: During 7 days post extubation
The primary endpoint is the proportion of patients with post-extubation acute respiratory failure, defined as the occurrence within 7 days of extubation of at least two of the following criteria: respiratory acidosis (pH \<7.35, PaCO2 \>45 mmHg), hypoxemia (PaO2 \<60 mmHg with a FiO2 \>40% or PaO2/FiO2\<150) and respiratory rate \>35/min.
次要结局
- Rate of pneumopathy(During 7 days post extubation)
- ROX index(8 hours during 7 days post extubation)
- Time for respiratory care(During 7 days post extubation)
- Rate of reintubation(During 7 days post extubation)