Effect of APRV and LTV on Lung Ventilation and Perfusion in Patients With Moderate-to-severe ARDS: a Single-center, Pilot Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Lung ventilation/perfusion matching
研究概览
简要总结
Low tidal volume ventilation (LTV) has been proposed and widely used in patients with acute respiratory distress syndrome (ARDS) to prevent ventilator-induced lung injury (VILI) and mitigate its effects. The LTV strategy is intended to protect the "baby lung" from overdistension while simultaneously allowing acutely injured tissue to continually collapse. Airway pressure release ventilation (APRV) is a highly effective strategy improving lung recruitment and oxygenation in clinical studies, but its effects on lung injury and mortality is debatable. Animal studies revealed that APRV could normalize post-injury heterogeneity and reduce the risk of VILI. Our objective was to investigate the impact of APRV and LTV on regional ventilation and perfusion distribution in ARDS patients by electrical impedance tomography (EIT).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients aged ≥18 and ≤80 years;
- •Moderate-to-severe ARDS patients according to the Berlin definition;
- •Endotracheal mechanical ventilation ≤48 h before enrollment;
- •Expected to require continuous invasive mechanical ventilation ≥72 h.
排除标准
- •Severe chronic obstructive pulmonary disease, severe asthma, pulmonary bulla, subcutaneous emphysema, mediastinal emphysema, etc;
- •Contraindications to the use of electrical impedance tomography (e.g., chest surgical wounds dressing or presence of pacemaker)；
- •Pulmonary interstitial lesions；
- •End-stage of chronic disease, with an expected survival period of <6 months；
- •Body mass index >35 kg/m2;
- •Refractory shock；
- •Intracranial hypertension；
- •Pregnant and parturient woman；
- •Intra-abdominal pressure persisted > 20 mmHg and could not be relieved within 24 hours；
- •Severe thoracic deformity；
- •Severe cardiac dysfunction；
- •Atrial fibrillation and other malignant arrhythmias that seriously affect cardiac output；
- •Pulmonary embolism；
- •Extracorporeal membrane oxygenation is needed；
- •Prone positioning was performed before randomization；
- •Patients who have participated in other clinical trials within 30 days；
- •Patients who have not signed informed consent.
结局指标
主要结局
Lung ventilation/perfusion matching
时间窗: 24hour
Lung ventilation/perfusion matching assessed by EIT
次要结局
- Dead-space% and shunting%(up to 72hour)
- Static respiratory compliance (Crs)(up to 72hour)
- Cardiac output(up to 72hour)
- Ventilator free days(up to 28days)
- Lung perfusion distrubution(up to 72hour)
- Duration of Intensive care units stay(up to 28days)
- Mortality after randomization(up to 28days)
- Lung ventilation distrubution(up to 72hour)
- Oxygenation index(up to 72hour)
- Arterial partial pressure of carbon dioxide (PaCO2)(up to 72hour)
- Right ventricular function(up to 72hour)
研究者
XiaoJing Zou,MD
Clinical Professor
Wuhan Union Hospital, China