Effect of PEEP=5cmH2O vs PEEP=0cmH2O PSV Strategies During SBT on Successful Disconnection From Mechanical Ventilation: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Reintubation rate
研究概览
简要总结
Mechanical ventilation is the most common means of life support in intensive care unit. Daily spontaneous breathing trial (SBT) is the most effective method to evaluate whether patients on mechanical ventilation can be removed from the ventilator, thus reducing mechanical ventilation duration and ventilator-related complications. Pressure support ventilation and T-piece ventilation are the two most commonly used SBT methods, lasting from 30 minutes to 2 hours. However, the parameter setting for SBT using PSV method has not been completely agreed, especially regarding the use of positive end-expiratory pressure (PEEP). Therefore, we intend to conduct a single-center, prospective, randomized, controlled study to evaluate the impact of PEEP=0cmH2O and PEEP=5cmH2O on extubation success rate and re-intubation rate in mechanically ventilated patients, to provide high-level clinical evidence on the use of PEEP for SBT in patients with mechanical ventilation, so as to reduce the duration of mechanical ventilation and complications related to mechanical ventilation.
详细描述
Patients who met the withdrawal screening criteria were randomly divided into groups for self-breathing test by PSV method with low pressure support level. Parameters of each group were as follows. In the experimental group, PS = 8 cmH2O, PEEP= 5 cmH2O, and FiO2 level was consistent with that before SBT.The control group: PSV mode, PS = 8 cmH2O, PEEP=0 cmH2O, FiO2 level was consistent with that before SBT.The duration of the spontaneous breathing test was 30 minutes, and the results of the spontaneous breathing test were evaluated at the end of the test.Endotracheal intubation was removed if the patient was successfully assessed for spontaneous breathing. Record the date and time of extubation.Patients with endotracheal intubation were treated with nasal hyperflow oxygen therapy for respiratory support.Patients with SBT failure were reconnected to the ventilator, and mechanical ventilation was given according to the ventilation mode and parameters before the spontaneous breathing test.The reasons for SBT failure were recorded and these patients were not randomized to SBT.If respiratory failure occurs within 48 hours after extubation, the attending physician decides the respiratory treatment plan.These patients were also not included in the subsequent SBT randomization.
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
- Single (Outcomes Assessor)
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
- •Older than 18;
- •Patients with mechanical ventilation for 24h;
- •Meet the screening standards for daily disconnection;
- •The study complies with the Declaration of Helsinki and China's regulations on clinical trial research, and the patient or his/her family members have informed and agreed to participate in the study.
排除标准
- •Patients undergoing tracheotomy;
- •Patients who refuse to be intubated again after endotracheal intubation is removed;
- •Patients on long-term mechanical ventilation: mechanical ventilation duration was continuous for 21 days, >6 h/d;
- •The attending physician decides the withdrawal plan (e.g., the potential pathology is more favorable to the specific withdrawal plan).
研究组 & 干预措施
PEEP=5cmH2O
In PSV mode,PS = 8 cmH2O,PEEP= 5 cmH2O, and FiO2 level was consistent with that before SBT
干预措施: PEEP (Procedure)
PEEP=0cmH2O
In PSV mode,PS = 8 cmH2O,PEEP=0 cmH2O, and FiO2 level was consistent with that before SBT
干预措施: PEEP (Procedure)
结局指标
主要结局
Reintubation rate
时间窗: during 48 hours after extubation
The reintubation rate of respiratory failure after extubation.
Extubation success rate
时间窗: during 48 hours after the first SBT
The success rate of extubation (during 48 hours after the first SBT if successfully removed from the ventilator).
次要结局
- Respiratory mechanical parameters(every 30 min during SBT up to one hour)
- Vital signs(every 15 min during SBT up to one hour and 30 min after extubation)
- No mechanical ventilation duration in ICU(From first transfer in ICU to transfer out ICU up to 28 days after randomization)
- Predictors of withdrawal of patients on mechanical ventilation(every 30 min during SBT up to one hour and before extubation)
- Length of ICU stay(From admission to discharge from ICU up to 28 days after randomization)
- Reintubation rate at 72 hours(during 72 hours after extubation)
- ICU mortality, 28-day mortality(28 day)
- Results of blood gas analysis(every 30 min during SBT up one hour to and 30min after extubation)
- Predictors of withdrawal of patients on mechanical ventilation(every 30 min during SBT up one hour and before extubation)
研究者
Liu ZiMeng
associate professor
First Affiliated Hospital, Sun Yat-Sen University