Customizing Spontaneous Breathing Trial After Aggressive Readiness Criteria Hastens Weaning in Low and Intermediate Risk Patients With Prevention: A Randomized Trial (SPEED-UP Trial).
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 940
- 试验地点
- 2
- 主要终点
- Time on mechanical ventilation
研究概览
简要总结
Hypothesis:
- In patients with less than 4 high risk factors for reintubation excluding body mass index >30 and hypercapnia during the spontaneous breathing trial (SBT) (low and intermediate risk for extubation failure), who receive preventive therapy with high flow nasal cannula (HFNC), the use of SBT with "HIGH minimal ventilator settings" (PS 8 + PEEP 5 cm H2O Vs PS 5 + PEEP 0 cm H2O), increase the proportion of patients with simple weaning (extubation after the first SBT).
- In patients with low and intermediate risk for extubation failure, who receive preventive therapy with HFNC, the use of Walsh screening criteria reduces the mechanical ventilation time compared with the use of Boles criteria.
Study design: This is a multicenter randomized open trial with 4 arms.
- Screening with PaO2/FiO2 > 180 and PEEP ≤ 10cm H2O; SBT with "HIGH minimal ventilator settings" (PS 8 + PEEP 5 cm H2O).
- Screening with PaO2/FiO2 > 180 and PEEP ≤ 10 cm H2O; SBT with "LOW minimal ventilator settings" (PS 5 + PEEP 0 cm H2O).
- Screening with PaO2/FiO2 ≥ 150 and PEEP ≤ 8 cm H2O; SBT with "HIGH minimal ventilator settings" (PS 8 + PEEP 5 cm H2O).
- Screening with PaO2/FiO2 ≥ 150 and PEEP ≤ 8 cm H2O; SBT with "LOW minimal ventilator settings" (PS 5 + PEEP 0 cm H2O).
Primary Outcome Measure:
-
- Percentage of first spontaneous breathing trial tolerated.
-
- Time on mechanical ventilation.
详细描述
Discontinuation of mechanical ventilation is a three-step process including:
-
- Readiness testing.
It evaluates the criteria to determine whether a patient might be able to be successfully and safety weaned from mechanical ventilation. The detection of readiness to try a spontaneous breathing test has controversial questions, in special concerning to oxygenation. From a conservative to an aggressive criteria we can list:
-
PaO2/FiO2 > 200 on PEEP ≤ 5 cm H2O (Esteban et al, 1999).
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PaO2/FiO2 ≥ 150 on PEEP ≤ 8 cm H2O (Boles et al, 2007).
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PaO2/FiO2 > 180 on PEEP ≤ 10 cm H2O (Walsh et al, 2004). We will compare Walsh and Boles in their different considerations for oxygenation criteria. Since Walsh criteria require a higher level of PEEP we understand that this criteria is more aggressive and in this way it allow to an early detection of readiness to SBT, but there is not any evidence of this statement.
-
- Spontaneous breathing trial (SBT). It tries to simulate (but not only) post-extubation work of breathing to promptly determine the time to extubation. There is also disparity about SBT minimal ventilator settings:
-
Inspiratory pressure with a range between automatic tube compensation (ATC) and inspiratory pressure of 5 - 8 cm H2O. Theoretically, if we use a higher support pressure during SBT it would be easier to pass the test. One could think that this may rise the risk of reintubation but there are various trials that have not confirmed this assumption.
-
Guidelines does not make any recommendation about expiratory pressurization, although the trials conducted use levels of Positive End-Expiratory Pressure (PEEP), between 0 and 5 cm H2O.
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Furthermore, we consider that "minimal ventilator settings" must be adjusted to additional parameters not previously considered, like preventive therapy applied after the extubation.
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All spontaneous breathing trials will last 30 minutes.
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- Extubation follow-up care. Therapies targeted to prevent post-extubation respiratory failure like high flow nasal cannula (HFNC), noninvasive ventilation (NIV) and respiratory physiotherapy for improving airway clearance, have been proposed.
The variability of preventive therapies and its settings generate different "minimal ventilator settings".
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Double (Care Provider, 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
- •Patients on mechanical ventilation for more than 24 hours with >= positive end-expiratory pressure
- •Patients with up to three high risk factors for extubation failure excluding hypercapnia during the spontaneous breathing trial and obese patients (BMI >30).
- •Patients fulfilling weaning criteria expected to have a spontaneous breathing trial in the following 24 hours.
- •Patients expected to be prevented with high-flow oxygen therapy after extubation.
排除标准
- •<18 years old.
- •Pregnant women.
- •Tracheostomized patients.
- •Accidental or self-extubated patients.
- •Obese (BMI >30) or hypercapnic patients during the spontaneous breathing trial.
结局指标
主要结局
Time on mechanical ventilation
时间窗: 1 month after intubation
Percentage of first spontaneous breathing trial tolerated
时间窗: 1 month after intubation
次要结局
- Reintubation rate(7 days after extubation)
- ICU and Hospital length of stay(3 months after ICU and Hospital admission)
- ICU and Hospital mortality rate(3 months after ICU and Hospital admission)
- Post-extubation respiratory failure rate(7 days after extubation)
- Sepsis and multiorgan failure rate(3 months after ICU and Hospital admission)
研究者
Gonzalo Hernandez Martinez
MD, PhD
Hospital Virgen de la Salud