Personalized Tidal Volume According to Cardiopulmonary Interactions in ARDS
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Tidal hyperinflation
研究概览
简要总结
Treatment of acute respiratory distress syndrome (ARDS) relies on invasive mechanical ventilation with supposedly protective settings (low tidal volume ventilation). Mortality of ARDS remains high in observational studies (40 to 50%). Approximately 30% of ARDS patients exhibit tidal hyperinflation despite low tidal volume ventilation, suggesting that personalization of tidal volume is required to improve ARDS prognostic. To date, reliable bedside tools to adjust tidal volume are lacking. Excessive tidal volume can be detected using computed tomography by quantification of tidal hyperinflation, but this technique is reserved to research studies and requires patient transport to imaging facility.
Mechanical ventilation generates cardio-pulmonary interaction, whose magnitude is influenced by tidal volume and respiratory system characteristics. Pulse pressure variation is a bedside tool with potential to quantify cardio-pulmonary interactions. Increasing tidal volume will decrease right ventricular preload and increase right ventricular afterload, hence maximizing cardio-pulmonary interactions.
The investigators hypothesize that pulse pressure variation might help to detect excessive tidal volume during a tidal volume challenge (i.e. stepwise increase in tidal volume)
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
- •Age greater then 18 years old
- •ARDS according to the BERLIN definition with PaO2/FiO2 ratio ≤ 150 mm Hg
- •invasive mechanical ventilation in volume controlled mode with tidal volume set to 6 ml/kg predicted body weight
- •use of sedation and neuromuscular-blocking agents
- •arterial catheter allowing computation of pulse contour cardiac output calibrated with thermodilution
- •central venous catheter implanted in the superior vena cava territory
- •esophageal balloon
- •Computed tomography planned by attending physician
排除标准
- •Previous inclusion in current study
- •Acute cor pulmonale
- •Arterial pH < 7.21 despite respiratory rate set to a maximum of 35/min
- •Pneumothorax or bronchopleural fistula
- •Decision to withdraw or withhold life sustaining treatment with 24 hours from inclusion
- •Contra-indication of transport to imaging facility
- •Intracranial hypertension
- •Tricuspid or pulmonary mechanical valve
- •Tricuspid or pulmonary infective endocarditis
- •Pace maker with intracardiac leads
- •Right ventricle tumor
- •Complete left bundle block
- •Intrathoracic metallic device
- •Cardiac arrythmia
- •Vesical pressure > 15 mm Hg
- •Lower limb amputation
- •Inferior vena cava thrombosis
- •Patient under an exclusion period relative to participation to another clinical trial
- •Patient under a legal protective measure
- •Patient not affiliated to social security
- •lac of patient/representative consent
- •Breast feeding
结局指标
主要结局
Tidal hyperinflation
时间窗: 5 minutes - This endpoint will be assessed 5 minutes after ventilatory adjustment
Difference between hyperinflated volume in computed tomography images acquired at end-inspiration (defined by the volume of voxels with CT-number \< -900) and hyperinflated volume in computed tomography images acquired at end-expiration (defined by the volume of voxels with CT-number \< -900). This difference will be standardized to predicted body weight using the formula of the ARMA trial.
次要结局
- Tidal volume(5 hours - This endpoint will be assessed through study completion (approximately 4-5 hours after study inclusion))