High Flow Oxygen During Spontaneous Breathing Trial in Patients With High Weaning Risk Failure: Impact on the Weaning Course at D7 From the First Spontaneous Breathing Trial. A Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 106
- 试验地点
- 2
- 主要终点
- Actuarial rate of extubation
研究概览
简要总结
In intensive care unit (ICU), mechanical ventilation (MV) is part of routine care.
Weaning phase is a daily preoccupation for the caregivers. Prolonged MV can lead to many complications. Failing the weaning phase expose the patient to the need for reintubation, that improves the mortality.
The caregiver faces a major problem, in one hand the need to wean properly and quickly and on the other the risk of reintubation.
In order to help the clinician making the good choice, the spontaneous breathing trial (SBT) is a key tool. The international literature provides the investigators many ways to perform the SBT. The most common is the T-piece; the patient is disconnected from the ventilator and connected to a T-piece that can provide supplemental oxygen. Another one is the Support pressure trial, the patient is still connected to the ventilator, but the setups are changed to recreate the T-piece conditions.
In many French ICU's, the SBT is performed by using a heat humidifier filter that is directly connected to the endotracheal tube, this filter allows the clinician to provide supplemental oxygen in accordance with the patient need.
In high risk for reintubation patients, the SBT can create physical stress, that lead to prolonged MV.
In our ICU, for those patients, the investigators perform the SBT by connecting the patient to a device that provides high flow oxygen trough endotracheal connector for tracheotomy.
The investigators hypothesis that high flow oxygen SBT, will allow the high risk for reintubation patients to succeed the SBT.
详细描述
The investigators proposed to compare 2 strategies for SBT in high risk for reintubation patients:
- Classic SBT (C-SBT)
- High Flow Oxygen SBT (HFO-SBT)
This prospective randomized study had 2 conjoint primary outcome:
- The HFO-SBT shows a better actuarial rate for extubation at day 7 from the begin of the weaning phase
- Compare the reintubation rate at D7 from the extubation
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Age > 18 yrs.
- •Admission in ICU
- •Mechanically ventilated > 24 hours
- •Mechanically ventilated using support ventilation mode
- •Patient with one of these criterion:
- •Cardiac disease (left ventricular dysfunction LVEF <46%, antecedent of ischemic heart disease, antecedent of acute pulmonary edema)
- •Respiratory disease (COPD, Emphysema, bronchectiasis, asthma, obesity-hypoventilation syndrome, restrictive pulmonary disease)
- •Informed and signed consent from the patient or next of kin.
排除标准
- •Head trauma as a cause for ICU admission
- •Neuromuscular disease prior ICU admission
- •Tracheotomized patient
- •Pregnancy
- •Decision not to forgo life sustaining therapy
- •Patient not affiliated with a social security organism
- •Adult private from his liberty with judicial decision
- •Patient that have already been included in the study
结局指标
主要结局
Actuarial rate of extubation
时间窗: Day 7
This prospective randomized study had 2 conjoint primary outcomes to ensure the safety for the patients: 1. The HFO-SBT shows a better actuarial rate for extubation at day 7 from the begin of the weaning phase 2. Compare the reintubation rate at D7 from the extubation This prospective randomized study had 2 conjoint primary outcomes to ensure the safety for the patients: 1. The HFO-SBT shows a better actuarial rate for extubation at day 7 from the begin of the weaning phase 2. Compare the reintubation rate at D7 from the extubation
Reintubation Rate
时间窗: Day 7
This prospective randomized study had 2 conjoint primary outcomes to ensure the safety for the patients: 1. The HFO-SBT shows a better actuarial rate for extubation at day 7 from the begin of the weaning phase 2. Compare the reintubation rate at D7 from the extubation
次要结局
- Success rate of the first SBT(Day 0)
- Rate of Ventilator Associated Pneumonia(Day 7)
- Ventilator free-days(Day 28)