Preserving Lung Volume During Weaning and Extubation. A Prospective, Multicenter Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,753
- 试验地点
- 2
- 主要终点
- Rate of Successful extubation
研究概览
简要总结
Introduction: At present, the best spontaneous breathing trial (SBT) during weaning from mechanical ventilation is a 30-min test with pressure support (PSV) 8 cmH2O without positive end-expiratory pressure (PEEP). There is a debate about the possible collapse of some alveolar units during such SBT and during extubation with continuous suctioning. A few experiences show extubation without suctioning as feasible and safe. Lung ultrasound is a non invasive and useful exploration tool to assess the lung aeration.
Hypothesis: Techniques aimed at preserving lung volume during SBT and extubation can yield higher rates of successful extubation. The preserved lung volume of each SBT and extubation strategy can be assessed by using lung ultrasound.
Primary objective: To define the rates of successful extubation in two extubation approaches aiming at different levels of lung volume preservation: standard SBT (30-min PSV 8 cmH2O without PEEP followed by extubation with continuous suctioning) versus experimental SBT (PSV8+ PEEP 5 cmH2O followed by extubation without suctioning). To define the lung aeration levels using the modified Lung Ultrasound Score (LUS) of each SBT strategy.
Secondary objectives: Reintubation rate, ICU and hospital stays, and mortality in each group. To define the diaphragm and intercostal thickness and thickening fraction in different levels of lung volume preservation.
Design: Prospective, multicenter, randomized study. Two opposing extubation strategies are compared in randomly assigned patients.The level of aeration is assessed using lung ultrasound.
详细描述
HYPOTHESIS Techniques aimed at preserving lung volume during SBT and extubation can yield higher rates of successful extubation. Lung Ultrasound Score (LUS) might be lower in techniques aiming to preserve lung volume suggesting less lung collapse.
METHODS
Patients with inclusion criteria and none exclusion criteria will be randomized to the follow strategies:
- Standard: PSV 8 cmH2O, PEEP 0 cmH2O for 30 minutes and, when successful, followed by extubation with continuous suctioning.
- Lung volume preservation: PSV 8 cmH2O, PEEP 5 cmH2O for 30 minutes and, when successful, followed by direct extubation without suctioning.
The randomization will be done with the built-in tool of the RedCap® Platform with computerized random number tables and blocks of n patients for each hospital. The investigators of each center will have a profile and a password to log into the RedCap and proceed with randomization of each patient. The investigator of each center will have access only to the data and randomization of his/her center.
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
- •Patients> 18 years who meet weaning criteria (see below)
- •More than 24 hours of mechanical ventilation (MV)
- •Signed Informed Consent by a substitute decision maker (SDM).
- •Weaning Criteria:
- •Suitable cough (Ability to raise secretions to the endotracheal tube) (or Maximal inspiratory pressure (MIP) < -15 cmH2O).
- •Absence of excessive secretions (<3 aspirations in the last 8 hours).
- •Resolution or improvement of the pathology that led to intubation.
- •Clinical stability (Heart Rate (HR) <140 bpm, Systolic Blood Pressure (SBP) 90-160, without vasopressors or at minimum doses).
- •Adequate oxygenation (SatO2> 90% with Inspiratory Fraction of oxygen (FiO2) <0.4).
- •Adequate ventilatory mechanics (Respiratory rate (RR) <35 rpm, Tidal Volume (TV) > 5 ml / kg, RR / TV <100 rpm/l).
- •Confident awareness level (Glasgow Coma Scale (GCS)> 13).
排除标准
- •tracheostomy, do-not-reintubate orders, decision of the responsible physician (e.g., due to a preference for a particular weaning technique according to the underlying pathology), absence of informed consent, mental incapacity without legal representation.
- •For ultrasound assessment: skilled explorer not present at the time of the SBT, inadequate ultrasound window. Known diaphragmatic paralysis.
结局指标
主要结局
Rate of Successful extubation
时间窗: 72 hours
Number of patients free of mechanical ventilation
Rate of Successful extubation
时间窗: 72 hours
Number of patients free of mechanical ventilation
次要结局
- ICU length of stay(90 days)
- Modified Lung Ultrasound Score (LUSm) at the end of the SBT and after extubation.(72 hours)
- Rate of Reintubation(72 hours)
- Rate of Hospital Mortality(90 days)
- Rate of ICU Mortality(90 days)
- Rate of Long term survival(90 days)
- Number of patients with tracheostomy(90 days)
- Hospital length of stay(90 days)
- Logistic regression for successful extubation(90 days)
- Rate of Hospital Mortality(90 days)
- Logistic regression for successful extubation(90 days)
- Number of patients with tracheostomy(90 days)
- Rate of Reintubation(72 hours)
- Rate of ICU Mortality(90 days)
- Rate of Long term survival(90 days)
- ICU length of stay(90 days)
- Hospital length of stay(90 days)
研究者
Carles Subirà Cuyàs
Research Coordinator
Althaia Xarxa Assistencial Universitària de Manresa