Criteria of Extubation Failure of Brain Injured Patients. Elaboration of a Prognostic Score.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Failure of extubation defined by the need of reintubation or the need for non-invasive ventilation
研究概览
简要总结
Identification of criteria associated with extubation failure of brain injured patients. Elaboration of a prognostic score of extubation failure of brain injured patients.
详细描述
Prospective clinical study in ICU with brain injured ventilated patients eligible to extubation.
Identification of clinical and biological criteria associated with failure of extubation.
Elaboration of a prognostic score of extubation failure of brain injured patients, based on criteria previously identified with multivariate analysis.
Failure of extubation is defined by the need of re-intubation or the need for non-invasive ventilation within 48 hours or more after extubation.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult brain injured patients ventilated eligible to discontinuation of mechanical ventilation
- •Stable respiratory and hemodynamic conditions
- •Ventilated patients for more than 48 hours
- •Adequate gaseous exchange (SpO2 ≥ 92% and respiratory rate ≤ 35/min, FiO2 ≤ 40%, positive end-expiratory pressure ≤ 5 cmH2O, pressure support ≤ 8 cmH2O, tidal volume ≥ 7mL/kg
- •Therapeutic extubation
排除标准
- •• Status epilepticus
- •Cerebrospinal infection
- •Patients under 15 years old
- •Mechanical ventilation of < 48 h
- •Spinal cord injury
- •Withdrawal of life support
结局指标
主要结局
Failure of extubation defined by the need of reintubation or the need for non-invasive ventilation
时间窗: at day 2
- Failure of extubation defined by the need of reintubation or the need for non-invasive ventilation within 48 hours or during ICU stay
次要结局
- Cause of brain injury (traumatic, ischemic, hemorrhagic or post-operative) at patient admission in ICU(at day 1)
- Complete neurological examination (Glasgow score, Coma Recovery Scale, FOUR score, cough, brain stem reflexes) just before extubation(at day 1)
- Severity scores (SAPS II, SOFA, GCS…) ) at patient admission in ICU(at ady 1)
- Glasgow Outcome Score (GOS)(at 6 months)
- Localisation of brain injury (hemispheric, supra- or sub-tentorial) at patient admission in ICU(at day 1)
- Delay of extubation from intubation day (number of days)(at day 1)
- cardiologic history (cardiac insufficiency or ischemic cardiomyopathy) during ICU stay(at day 1)
- - Cause of extubation failure before 48 hours (respiratory, hemodynamic, aspiration, ...)(at day 2)
- - Pulmonary examination (arterial gasometry, ventilatory parameters: mode, frequency, positive end expiratory pressure, inspiratory pressure, tidal volume, minute ventilation, oxygen level) just before extubation(at day 1)