Effects of Time-controlled Adaptive Ventilation (TCAV) and Volume Control Ventilation (VCV) on the Distribution of Aerated Lung Parenchyma in Patients With Acute Respiratory Distress Syndrome (ARDS): a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Percentage of end-expiratory non aerated lung parenchyma
研究概览
简要总结
Acute respiratory distress syndrome (ARDS) is a severe form of acute respiratory failure with mortality rates reaching as high as 35%. Management of ARDS is based on the treatment (if possible) of the underlying cause of ARDS and on invasive mechanical ventilation with positive expiratory pressure (PEEP). Another strategy of invasive ventilation, Time-Controlled Adaptative Ventilation (TCAV), is the application of specific settings to the airway pressure release ventilation (APRV) mode.
TCAV is based on a prolonged time at plateau pressure, creating a phase of continuous positive pressure, associated with brief release phases allowing the elimination of carbon dioxide. In prospective and retrospective clinical reviews, as well as in experimental animal studies, TCAV has demonstrated improvements in oxygenation and lung function, with the ability to prevent ARDS.
The thoracic computed tomography (CT) scan evaluates lung recruitment (re-aeration by positive pressure of non-ventilated lung territories) and the adverse effects of positive pressure on the parenchyma (hyperinflation).
The objective of this study is to evaluate, with CT scans performed to assess lungs of patients with ARDS, the effects of TCAV compared to a standard volumetric controlled ventilation, by measuring alveolar recruitment and over-distension.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •ARDS according to the Berlin definition
- •invasive ventilation for no longer than 72 hours
- •patient requiring a diagnostic thoracic CT scan
- •consent of a family member or the person of trust
- •social security affiliation
排除标准
- •Use of iodinated contrast media injection before CT acquisitions
- •ARDS criteria present during 72 hours or more
- •Severe COPD
- •Pneumothorax or other barotrauma-related complication
- •Right ventricular failure other than acute cor pulmonale
- •Absence of sedative agents and neuromuscular blockade
- •Severe hemodynamic instability (norepinephrine > 0.5 µg/kg/min)
- •VA-ECMO assistance
- •Pregnancy
- •Absence of the capacity to give consent before admission to the ICU
结局指标
主要结局
Percentage of end-expiratory non aerated lung parenchyma
时间窗: during procedure (10 minutes)
Percentage of non aerated lung parenchyma defined as % of lung at -100 to +100 Hounsfield Units (HU) divided by total lung weight, at the end of expiration.
次要结局
- Correlation between transpulmonary driving pressure and tidal hyperinflation in TCAV(10 minutes)
- End-inspiratory overdistention in TCAV(10 minutes)
- Tidal hyperinflation in TCAV(10 minutes)
- Correlation between driving pressure and tidal hyperinflation in TCAV(10 minutes)
- Atelectrauma in TCAV and VCV(10 minutes)
研究者
PEQUIGNOT Benjamin
Dr
Central Hospital, Nancy, France