Right-Sizing Tidal Volume in ARDS: Using the Stress Index to Optimize Mechanical Ventilation to Individual Respiratory Mechanics
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Comparison of ARDSnet-optimized and protocol-optimized tidal volume
研究概览
简要总结
Acute respiratory distress syndrome (ARDS) is a widely prevalent and morbid disease for which the current standard treatment is supportive care and avoidance of complications with lung-protective ventilation. Lower-tidal volume ventilation has been largely accepted as a means of lung protective ventilation, but the mechanism for its effectiveness is not yet clear, and debate remains as to how best to choose positive end-expiratory pressure (PEEP). Reduction in driving pressure (plateau pressure minus PEEP) has been suggested as a possible means to minimize ventilator-induced lung injury. This protocol aims to identify the range of safe paired-settings of PEEP and tidal volume, with selection guided by driving pressure and the stress index, a tool to recognize potential lung hyperinflation during mechanical ventilation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •Admitted to the Intensive Care Unit
- •Receiving invasive mechanical ventilation via endotracheal or tracheostomy tube
- •Presence of ARDS by Berlin Criteria (acute onset bilateral pulmonary infiltrates incompletely explained by left heart failure together with a PaO2/FiO2 of <300 or SpO2/FiO2 <315)
排除标准
- •Inability to obtain surrogate consent
- •Presence of specified comorbidities:
- •pre-existing severe chronic obstructive pulmonary disease, defined as FEV1 documented < 1L or baseline hypercapnia
- •cerebral edema
- •known intra-cranial abnormality
- •acute coronary syndrome
- •Endotracheal or tracheostomy cuff leak
- •Chest tube with persistent air leak
- •Severe hemodynamic instability (defined as attending judgment that the patient is unable to safely tolerate ventilator manipulations)
- •Presence of spontaneous respiratory activity as evidenced by examination of the ventilator waveform tracing
- •Intrinsic PEEP of > 5 cmH2O
- •Assessment of study staff or patient's attending physician that the patient would not be a good study participant
研究组 & 干预措施
Intervention Arm
干预措施: Recruitment Maneuver with PEEP and Tidal Volume Optimization (Procedure)
结局指标
主要结局
Comparison of ARDSnet-optimized and protocol-optimized tidal volume
时间窗: Completion of the study intervention, less than 1 day
Mean absolute difference between tidal volume in cc/kg PBW prescribed by ARDSnet settings on ARDSnet PEEP versus maximal protective tidal volume defined by stress index \<1.05 at the ARDSnet PEEP on experimental protocol.
Comparison of ARDSnet-optimized and protocol-optimized driving pressure
时间窗: Completion of the study intervention, less than 1 day
Mean difference in driving pressure prescribed by ARDSnet settings versus at lowest measured possible driving pressure that achieves equivalent minute ventilation as ARDSnet table with respiratory rate \< or = 35 per minute and SI \<1.05.
次要结局
- Comparison of ARDSnet-optimized and protocol-optimized PEEP(Completion of the study intervention, less than 1 day)
- Comparison of ARDSnet-optimized and protocol-optimized elastance(Completion of the study intervention, less than 1 day)
研究者
Andrew McKown
Fellow in Pulmonary and Critical Care Medicine
Vanderbilt University