Early Use of Airway Pressure Release Ventilation (APRV) in Patients With Acute Respiratory Distress Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Mechanical ventilation free days
研究概览
简要总结
Airway pressure release ventilation (APRV) is a time-cycled, pressure controlled, intermittent mandatory ventilation mode with extreme inverse I:E ratios. Currently it is considered as a non-conventional ventilatory mode. The investigators aim to compare APRV with conventional mechanical ventilation (MV) in patients with acute respiratory distress syndrome (ARDS).
详细描述
Despite the advances in technology and ventilatory modes, mortality of ARDS is still around 40%. Besides prone positioning, the best approach of management is low tidal volume ventilation (LTV). This 'protective ventilation' strategy is not aways effective to improve oxygenation and is associated with an increased requirement of sedation and neuromuscular blocking agents, which increase length of stay and morbidity. APRV is a ventilatory mode based on relatively high and sustained continuous positive pressure, combined with a short phase of release to allow carbon dioxide removal. It also allows unrestricted spontaneous breathing throughout respiration, independent of the ventilator cycle. Providing sustained inflation while limiting duration and frequency of release phase permits limiting volume loss, resulting in progressive and improved alveolar recruitment, an increased alveolar surface area available for gas exchange and improved ventilation-perfusion matching.
In this multi-center, prospective, randomized, controlled, open trial, the investigators aim to compare the effects and safety of the early application of time-controlled adaptive method of APRV and conventional ventilation with LTV strategy in patients with severe to moderate ARDS.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute respiratory distress syndrome, according to the Berlin definition of ARDS, with adjusted pO2/FiO2 for altitude <300, and less than 48 h of endotracheal mechanical ventilation
排除标准
- •Pregnancy
- •Less than 18 years-old
- •Expected duration of mechanical ventilation less than 48 h
- •Preexisting conditions with an expected 3-month mortality exceeding 50%
- •Concurrent chemotherapy
- •Confirmed intracranial hypertension
- •Catastrophic cranial trauma or neuromuscular disorders that are known to prolong mechanical ventilation
- •Pneumothorax at enrollment (resolved or not)
- •Do-not-resuscitate order
研究组 & 干预措施
Time-controlled adaptive APRV
Airway Pressure Release Ventilation with Time-controlled adaptive ventilation method. Allowing for spontaneous breathing.
干预措施: APRV. General Electric Healthcare Engstrom ventilator system (Device)
Conventional ventilation
Protective lung conventional strategy with volume-controlled ventilation (VCV) or pressure-controlled ventilation (PCV) mode, with low tidal volume and adequate positive end expiratory pressure (PEEP) level.
干预措施: Conventional. General Electric Healthcare Engstrom ventilator system (Device)
结局指标
主要结局
Mechanical ventilation free days
时间窗: 28 days
次要结局
- All causes mortality(28 days)
- Tracheostomy rate(28 days)
- ICU length of stay(28 days)
- Hospital length of stay(60 days)
- Average expiratory time(7 days)
- oxygen partial pressure (pO2)(7 days)
- Average of prone position sessions(7 days)
- Mean airway pressure, peak airway pressure, maximum P high(7 days)
- Rate of neuromuscular blocking agents utilization(7 days)
- Prone position rate(7 days)
- Minute ventilation(7 days)
- pCO2 (carbon dioxide partial pressure)(7 days)
- Richmond Sedation-Agitation Scale(7 days)
- Mean arterial pressure(7 days)
- Maximum dosage of vasopressors requirement(7 days)
- Average dose of propofol use(7 days)
- Rate of recruitment maneuvers(7 days)
研究者
Miguel Á Ibarra-Estrada
Principal investigator
Hospital Civil de Guadalajara