PRessure suppOrT vEntilation + Sigh in aCuTe hypoxemIc respiratOry Failure patieNts (PROTECTION): a Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 258
- 试验地点
- 21
- 主要终点
- Clinical feasibility of PSV+Sigh vs. standard of carde (PSV)
研究概览
简要总结
Mortality of intubated acute hypoxemic respiratory failure (AHRF) and acute respiratory distress syndrome (ARDS) patients remains considerably high (around 40%) (Bellani 2016). Early implementation of a specific mechanical ventilation mode that enhances lung protection in patients with mild to moderate AHRF and ARDS on spontaneous breathing may have a tremendous impact on clinical practice.
Previous studies showed that the addition of cyclic short recruitment maneuvers (Sigh) to assisted mechanical ventilation: improves oxygenation without increasing ventilation pressures and FiO2; decreases the tidal volumes by decreasing the patient's inspiratory drive; increases the EELV by regional alveolar recruitment; decreases regional heterogeneity of lung parenchyma; decreases patients' inspiratory efforts limiting transpulmonary pressure; improves regional compliances. Thus, physiologic studies generated the hypothesis that addition of Sigh to pressure support ventilation (PSV, the most common assisted mechanical ventilation mode) might decrease ventilation pressures and FiO2, and limit regional lung strain and stress through various synergic mechanisms potentially yielding decreased risk of VILI, faster weaning and improved clinical outcomes.
The investigators conceived a pilot RCT to verify clinical feasibility of the addition of Sigh to PSV in comparison to standard PSV.
The investigators will enrol 258 intubated spontaneously breathing patients with mild to moderate AHRF and ARDS admitted to the ICU.
Patients will be randomized through an online automatic centralized and computerized system to the following study groups (1:1 ratio):
- PSV group: will be treated by protective PSV settings until day 28 or death or performance of spontaneous breathing trial (SBT);
- PSV+Sigh group: will be treated by protective PSV settings with the addition of Sigh until day 28 or death or performance of spontaneous breathing trial (SBT).
Indications on ventilation settings, weaning, spontaneous breathing trial and rescue treatment will be specified.
详细描述
Steering committee: Tommaso Mauri, Laurent Brochard, Jean-Michel Constantin, Giuseppe Foti, Claude Guerin, Jordi Mancebo, Paolo Pelosi, Marco Ranieri, Antonio Pesenti Statistical support: Carla Fornari and Sara Conti
Specific aims
This pilot RCT will serve to test the hypothesis that application of PSV+Sigh in spontaneously breathing intubated patients with mild to moderate AHRF and ARDS is feasible and to collect preliminary data on the safety of such an approach.
Methods
Study design. The investigators will conduct a pilot RCT on intubated spontaneously breathing patients with mild to moderate AHRF and ARDS admitted to the ICU.
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 intubated since >24 hours and ≤7 days,
- •undergoing PSV since >4 and ≤24 hours,
- •PaO2/FiO2 ratio ≤300 mmHg (measured at clinical positive end-expiratory pressure [PEEP] and FiO2 values)
- •clinical PEEP ≥5 cmH2O,
- •Richmond Agitation-Sedation Scale (RASS) value of -2 to 0
排除标准
- •patients with PEEP ≥15 cmH2O;
- •PaCO2 >60 mmHg;
- •Arterial pH <7.30;
- •Age <18 year-old;
- •PaO2/FiO2 ratio ≤100 mmHg (measured at clinical PEEP and FiO2 values);
- •central nervous system or neuromuscular disorders;
- •history of severe chronic obstructive pulmonary disease or fibrosis;
- •AHRF fully explained by cardiac failure or fluid overload (e.g., left ventricle ejection fraction ≤40% with no other risk factor);
- •impossibility to titrate sedation to desired RASS value of -2 to 0;
- •evidence of active air leak from the lung (e.g., pneumothorax);
- •cardiovascular instability (e.g., systolic blood pressure [SBP] <90 mmHg despite vasopressors);
- •clinical suspect of elevated intracranial pressure;
- •extracorporeal support;
- •moribund status;
- •refusal by the attending physician.
结局指标
主要结局
Clinical feasibility of PSV+Sigh vs. standard of carde (PSV)
时间窗: 2 years
Feasibility will be assessed by measuring the number of patients in each group experiencing at least one of the following failure criteria: * switch to controlled ventilation following presence of predefined criteria; * use of PEEP ≥15 cmH2O, prone positioning, inhaled nitric oxide, extracorporeal membrane oxygenation; * re-intubation within 48 hours from extubation following predefined criteria. Based on previous data, the expected rate of failure in patients undergoing PSV will be 22% and we hypothesize a rate of 15% for patients in the PSV+Sigh group. Furthermore, we assume a non-inferiority of the treatment with PSV+Sigh, with a tolerance of 5%. Thus, a sample size of 258 patients (with 129 patients per study arm) will be sufficient to assess feasibility of the PSV+Sigh strategy in this pilot phase with power of 0.8 and alpha 0.05.
次要结局
- Quantification of the prevalence of Sigh responders(2 years)
- Clinical safety of PSV+Sigh comparing adverse events between 2 groups(2 years)
- Ventilator-free days(2 years)
- Patients' comfort by visual analog scale(2 years)
- Mortality(2 years)
- Number of days on assisted ventilation until day 28(28 days)