Non Pharmacological Randomized Clinical Trial Designed to Evaluate the Difference of the Duration of Weaning Process From the Ventilator Between Protocol-driven Weaned Patients and Clinical-driven Weaned Patients.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- duration of weaning
研究概览
简要总结
The purpose of this study is to evaluate the difference of the duration of weaning process from the ventilator between protocol-driven weaned patients and clinical judgment driven weaned patients.
详细描述
All patients with prolonged weaning and who required tracheostomy are enrolled in the study. These patients are randomized as "Case or Control" by a computer program.
Patients can start the weaning process when the acute phase of the respiratory failure has been resolved and pressure support ventilation was setted.
For all this patients are calculated modified-BWAP(BWAP-M) and TOBIN indexes. The "Case" patients started the weaning protocol process only if BWAP-M value is more than 15 or BWAP-M 10-15 with Tobin index < 100.
If not, the BWAP-M and Tobin will be calculated every day. The Control patients will start weaning by clinical judgement even if the BWAP-M value is less than 10.
For all patients are calculated: the duration of weaning process, the ICU length of stay and the duration of the mechanical ventilation.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •all patients that are clinically identified as prolonged to wean (failed 3 spontaneous breathing trials or 7 days or more of mechanical ventilation after the initial unsuccessful trial) and tracheostomized in ICU
- •improvement or resolution of the underlying causes of acute respiratory failure ratio between pressure partial artery of oxygen and fraction inspired oxygen (PaO2/FiO2) >200 with fraction inspired oxygen (FiO2)< 0,
- •pressure supported ventilation at the time of enrollment.
排除标准
- •patients assessed as easy weaning and not tracheostomized;
- •patients already tracheostomized on admission to ICU.
结局指标
主要结局
duration of weaning
时间窗: within the first 15 days (plus or minus 5 days) after start of weaning
次要结局
- duration of mechanical ventilation(within the first 12 days (plus or minus 10 days) after start of mechanical ventilation)
研究者
ELENA PELI,MD
dirigente medico
Università degli Studi di Brescia