Identification of Echocardiographic Criteria Predictive of the Inefficacy and/or the Unsafeness of Recruitment Maneuvers in Patients Suffering From Acute Respiratory Distress Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Efficacy and safety of recruitment maneuvers in patients with Acute Respiratory Distress Syndrome.
研究概览
简要总结
The purpose of the study RVSTAR is to evaluate whether echocardiographic criteria exploring the right ventricle can predict the inefficacy and/or the unsafeness of recruitment maneuvers in patients suffering from acute respiratory distress syndrome
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 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
- •Endotracheal mechanical ventilation for acute hypoxemic respiratory failure lasting for one week or less
- •A ratio of the partial pressure of arterial oxygen (PaO2 measured in millimeters of mercury) to the fraction of inspired oxygen (FiO2 which is unitless) of 300 mmHg or less and inspired fraction of oxygen FiO2 of more than 50 %
- •A positive end-expiratory pressure of 5 cm of water or higher
- •A tidal volume of 6 to 8 ml per kilogram of predicted body weight
- •Bilateral opacities on chest radiography not fully explained by effusions, lobar/lung collapse, or nodules
- •Respiratory failure not fully explained by cardiac failure or fluid overload
- •Written and informed consent
- •Adult patients at least 18 years of age
- •Ventilatory criteria (PaO2/FiO2 of 300 mmHg or less and Positive End Expiratory Pressure of 5 cm of water or higher) and radiologic criteria (Bilateral opacities on chest radiography not fully explained by effusions, lobar/lung collapse, or nodules) lasting more than 24 hours
排除标准
- •Endotracheal mechanical ventilation for acute hypoxemic respiratory failure lasting for more than one week
- •Age younger than 18 years old
- •No written and informed consent
- •Known pregnancy and/or breastfeeding
- •Increased intracranial pressure
- •A ratio of the partial pressure of arterial oxygen (PaO2 measured in millimeters of mercury) to the fraction of inspired oxygen (FiO2 which is unitless) higher than 300 mmHg
- •Positive end expiratory pressure of less than 5 mmHg
- •Ventilatory criteria (PaO2/FiO2 of 300 mmHg or less and Positive End Expiratory Pressure of 5 cm of water or higher) and radiologic criteria (Bilateral opacities on chest radiography not fully explained by effusions, lobar/lung collapse, or nodules) lasting less than 24 hours
- •Severe chronic respiratory disease requiring long-term oxygen therapy or mechanical ventilation at home
- •Severe chronic liver disease
- •Barotrauma such as pneumothorax
- •Hemodynamic failure needing more than 3 milligrams per hour of noradrenalin and/or more than 2 milligrams per hour of adrenalin and or rising doses of vasopressors and/or vascular filling exceeding 500 milliliters in the preceding hour
- •Arrhythmias such as : ventricular tachycardia, ventricular fibrillation, third degree atrioventricular block
- •Atrial fibrillation
结局指标
主要结局
Efficacy and safety of recruitment maneuvers in patients with Acute Respiratory Distress Syndrome.
时间窗: Up to 2 years
A recruitment maneuver is considered effective if the partial pressure of oxygen in arterial blood PaO2 measured one hour after the completion of recruitment maneuver is 20 % higher than PaO2 before recruitment maneuver. A recruitment maneuver is considered unsafe if systolic arterial pressure decreases 40 % under its value before recruitment maneuver and/or if systolic arterial pressure decreases under 70 mmHg and/or if arrhythmias (third degree atrio-ventricular block, ventricular tachycardia, ventricular fibrillation, atrial fibrillation)occur during the achievement of recruitment maneuver in patients suffering from Acute Respiratory Distress Syndrome. Can echocardiography predict the inefficacy and/or unsafeness of recruitment maneuvers in patients suffering from Acute Respiratory Distress Syndrom ?
次要结局
- Feasibility of the measurement of Longitudinal Strain and Strain Rate of the right ventricle in patients suffering from Acute Respiratory Distress Syndrome.(Up to 2 years)
- Evaluate the effect of the inefficacy and/or of the unsafeness of the recruitment maneuver on the future of the patient suffering from Acute Respiratory Distress Syndrome.(Up to 2 years)
- Comparison of the results of echocardiographic measurements between the group CONTROL and the group FAILURE.(Up to 2 years)
研究者
Guillaume BESCH
MD
Centre Hospitalier Universitaire de Besancon