A Randomized Trial of High Flow Oxygen Therapy in Spontaneous Breathing Trial on Weaning in Mechanical Ventilated Patients.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- Rate of weaning failure
研究概览
简要总结
This clinical trial is aimed to show a spontaneous breathing trial using high flow oxygen therapy may lower weaning failure rate and reintubation rate than using T-piece.
详细描述
We project to test the effect of high flow oxygen therapy in spontaneous breathing trial on weaning in mechanical ventilated patients. Patients will be randomly assigned to undergo a spontaneous breathing trial in one of two ways: with a T-piece therapy or with high flow oxygen therapy. Primary end-points are rate of weaning failure and rate of reintubation within 48 hr of extubation. Weaning failure is defined as failed to spontaneous breathing trial or reintubation within 48 hr of extubation. Secondary end-points are ICU mortality, in-hospital mortality, ICU length of stay, time to reintubation after extubation. Study sample was calculated to detect ability of high flow oxygen therapy to reduce weaning failure from 42 to 15 percent, at two-tailed alpha error of 5% and power of 85% and 98 patients are needed in each arm.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients aged 18 years or more, both gender
- •Receiving endotracheal intubation and mechanical ventilation for more than 12 hours
- •Recovery from the precipitating illness
- •Weaning readiness according to the following criteria :
- •Respiratory criteria :
- •PaO2:FIO2 >150 with FIO2 ≤0.4, PEEP <8 cm H2O
- •Arterial pH >7.35
- •Rapid shallow breathing index (RSBI) < 105
- •Maximum inspiratory pressure (MIP) < -20 cm H20
- •Clinical criteria :
- •Absence of electrocardiographic signs of myocardial ischemia
- •No vasoactive drugs, or vital signs are stable with using vasoactive drugs
- •Heart rate <140/min,
- •Hemoglobin >8 g/dL
- •Temperature <38°C
- •No need for sedatives, or mental status are stable with sedatives
- •Presence of respiratory stimulus, and appropriate spontaneous cough
- •Absence of excessive tracheobronchial secretions
排除标准
- •Tracheostomy status
- •Decision to stop life-supportive therapies before enrollment
研究组 & 干预措施
Spontaneous breathing trial with T-piece
Patients were randomized to undergo a spontaneous breathing trial with T-piece that is connected on endotracheal tube. Patients tolerating the spontaneous breathing trial underwent extubation.
Spontaneous breathing trial with high flow oxygen therapy
Patients were randomized to undergo a spontaneous breathing trial with high flow oxygen therapy that is connected on endotracheal tube. Patients tolerating the spontaneous breathing trial underwent extubation.
干预措施: High flow oxygen therapy in spontaneous breathing trial (Procedure)
结局指标
主要结局
Rate of weaning failure
时间窗: Day 2
Weaning failure is defined as failed to spontaneous breathing trial or reintubation within 48 hr of extubation
次要结局
- In-hospital mortality(From the date of randomization until the date of in-hospital death from any cause, assessed up to 3 months.)
- ICU length of stay(Through the study completion, an average of 1 weeks)
- ICU mortality(From the date of randomization until the date of ICU death from any cause, assessed up to 1 month.)
- Rate of reintubation within 48 hr of extubation(Day 2)
- Time to reintubation after extubation(From the date of extubation until the date of reintubation, assessed up to 1 weeks.)
研究者
Sang-Min Lee
Associate Professor
Seoul National University Hospital