Impact of the Transpulmonary Pressure on Right Ventricle Function in Acute Respiratory Distress Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Right ventricle failure
研究概览
简要总结
Pulmonary distension induced by mechanical ventilation physiologically alters right ventricle pre and after-load, hence might lead to right ventricle failure. The hypothesis is that in Acute Respiratory Distress Syndrome, the occurence of a right ventricle failure under lung protective ventilation might :
i) be correlated to the transpulmonary pressure level, ii) lead to global heart failure, iii) and extremely result in poor outcome and death.
The primary objective is to test the impact of transpulmonary pressure on right ventricular function in Acute Respiratory Distress Syndrome in adults and children.
Secondary objectives are :
i) to compare thresholds of transpulmonary pressure associated with right ventricle failure between children and adults.
ii) to assess if there is an association between transpulmonary pressure and morbidity and mortality.
- For pediatric patients, a specific monitoring with electrical impedance tomography (EIT) will allow:
- To assess if the transpulmonary pressure is associated with the level of regional pulmonary overdistention (or collapse) on electrical impedance tomography.(EIT)
- To assess if there is an association between the occurrence of right ventricular failure, and distribution of ventilation on EIT.
详细描述
Acute Respiratory Distress Syndrome (ARDS) is an acute inflammatory lung injury associated with a high pulmonary vascular permeability, leading to acute respiratory failure. Positive pressure mechanical ventilation,improves survival but might lead to ventilator-induced lung injury (VILI) and right ventricular failure. This hemodynamic effect is more important when compliance is decreased, especially in ARDS.
The use of long protective ventilation (with low tidal volumes and low plateau pressures) has improved prognosis of ARDS in adult patients. However, tidal volume and plateau pressures do not always reflect the lung deformation and the stress induced by the ventilation; these variables depend on the characteristics of the patient's respiratory system. Therefore, management focuses on ventilation strategies according to these characteristics.
Among tools used to evaluate respiratory physiological parameters, the esophageal pressure measurement is easily feasible at the bedside, and well estimates pleural pressure and pulmonary distension. During invasive ventilation, transpulmonary pressure (PL) can be obtained with the difference between the airway pressure and the esophageal pressure. Calculation of transpulmonary pressure in ARDS allows optimal ventilator management of adult and children treated for ARDS.
Although individualized ventilation techniques have shown some benefits in ARDS, studies have failed to show that survival could be improved by such strategies. This lack of efficacy could be partly explained by the hemodynamic impact of ventilation-induced pulmonary distension. It therefore seems essential to combine a robust assessment of right ventricular function with measurements of transpulmonary pressure in order to know the real hemodynamic impact of positive pressure ventilation in ARDS in adults and children.
The primary objective is to test the impact of transpulmonary pressure on right ventricular functionin ARDS adults and children.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 1 Month 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over one month
- •Patients with mild to severe ARDS (onset within 48 hours). ARDS definition will follow Berlin guidelines for adults, and Pediatric Acute Lung Injury Consensus Conference (PALICC) guidelines for children
- •Signed consent
排除标准
- •Neonates less than 28 days-old
- •Pregnancy or breastfeeding
- •Any contra-indication to esophageal manometry (less than one month esophagus surgery, bronchopleural or esotracheal fistula, latex allergy)
- •No social care
研究组 & 干预措施
Acute Respiratory Distress Syndrome
Children of more than one month of age and adults hospitalized in Intensive Care Unit for Acute Respiratory Distress Syndrome.
干预措施: Pneumotachograph (Other)
Acute Respiratory Distress Syndrome
Children of more than one month of age and adults hospitalized in Intensive Care Unit for Acute Respiratory Distress Syndrome.
干预措施: Esophageal catheter (Other)
Acute Respiratory Distress Syndrome
Children of more than one month of age and adults hospitalized in Intensive Care Unit for Acute Respiratory Distress Syndrome.
干预措施: Transthoracic and / or transesophageal cardiac ultrasound (Other)
Acute Respiratory Distress Syndrome
Children of more than one month of age and adults hospitalized in Intensive Care Unit for Acute Respiratory Distress Syndrome.
干预措施: Electrical impedance tomography (EIT) for pediatric patients (Other)
结局指标
主要结局
Right ventricle failure
时间窗: Three days
Right ventricle failure is defined, by ultrasound, as a composite criteria associating : * end-diastolic right ventricle/left ventricle area ratio \> 0.6 and/or Acute Cor Pulmonale (assocation with a septal dyskinesia), * and/or a tricuspid annular plane systolic excursion \< 1,6 cm (adults), z-score \< -2 (children), * and/or a doppler-derived tricuspid lateral annular systolic velocity (S wave) \< 10 cm/s, * and/or a two-dimensional Fractional Area Change (defined as end-diastolic area - end-systolic area)/end-diastolic area x100) \< 35%, * and/or a peak right ventricle free wall 2D strain \< -30% (adults), z-score \< 2 (children).
次要结局
- Oesophageal pressure(Three days)
- Vaso-Active Inotrope Score (VIS)(Three days)
- Transpulmonary pressure calculation(Three days)
- Mortality at 28 days(28 days)
- Eletrical impedance tomography(3 days)
- Pediatric logistic organ dysfunction score(Three days)
- Sepsis-related Organ Function Assessement score(Three days)
- Invasive and non invasive ventilation free days(3 months after hospitalization in Intensive Care Unit)
- Airways pressure(Three days)
- Duration of treatment with vasoactive or inotropic drugs(3 months after hospitalization in Intensive Care Unit)
- Length of hospitalization(3 months after hospitalization in Intensive Care Unit)
- Mortality in Intensive Care Unit(3 months after hospitalization in Intensive Care Unit)
- Lung and Chest Wall compliance(Three days)