Effect of Deflating the Tracheal Cuff During Ventilatory Disconnections on Weaning Time
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 195
- 试验地点
- 2
- 主要终点
- Weaning Time
研究概览
简要总结
The purpose of this study is to determine whether deflating the tracheal cuff in tracheostomized patients, during disconnections from ventilatory support along the weaning phase shortens the weaning time.
详细描述
Randomized controlled trial.
Study protocol: patients will be eligible for the study after fulfilling standard criteria for weaning initiation and stratified for risk of aspiration (drink test)into two categories:
- Low/moderate risk patients (see later).
- High risk patients (spontaneous aspiration of pharyngeal secretions), will be excluded from the study.
After this evaluation patients will be randomized (concealed allocation) stratifying with the tracheostomy indication.
Weaning and Decannulation Protocol: Attempts to discontinue mechanical ventilation (MV) will be initiated when the tracheostomized patients fulfill the criteria (recovery from the precipitating illness; respiratory criteria consisting of a PaO2/fraction of inspired oxygen ratio of >150 mm Hg with a positive end-expiratory pressure <8 cm H2O, and an arterial pH >7.32; and clinical criteria consisting of the absence of myocardial ischemia determined by ECG, no need for vasoactive drugs or dopamine ≤5 µg/kg/min, a heart rate <140 beats/min, haemoglobin concentration >8 g/dL, temperature <38°C, no need for sedative drugs, presence of respiratory stimulus and spontaneous cough deemed clinically appropriate. Patients will be screened daily for these criteria).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •tracheostomized patients for any of the following reasons:
- •Prolonged time under mechanical ventilation (>21 days) or prolonged weaning.
- •Motor component of Glasgow Coma Score <6 points or inability to adequate manage the airway (>2 aspirations every 8 hours).
排除标准
- •High risk of aspiration (neuromuscular disease affecting bulbar functions, tracheostomies indicated as a part of a surgical procedure involving the upper airway or high risk of aspiration observed after specific evaluation previous to randomization).
- •Death before starting weaning attempts.
结局指标
主要结局
Weaning Time
时间窗: 6 months
The weaning time starts at the first disconnection from mechanical ventilation lasting \>30 minutes and ends after the patient tolerate 24 consecutive hours disconnected from mechanical ventilation.
次要结局
- Tracheobronchitis and Pneumonia(6 months)
研究者
Gonzalo Hernandez Martinez
FEA Medicina Intensiva
Hospital Virgen de la Salud