Identifying the Optimal Positive End-Expiratory Pressure Level to Ventilate Patients After Bilateral Lung Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 47
- 试验地点
- 2
- 主要终点
- Lung Compliance
研究概览
简要总结
Lung Transplantation (LuTX) is the curative treatment for selected patients with end-stage lung disease. Primary Graft Dysfunction (PGD), a specific form of respiratory failure occurring within the first 72 hours after graft reperfusion, represents the most common complication after LuTX.
Actual recommendation regarding management of mechanical ventilation of the lung graft immediately after LuTX are based only on opinion experts and not on clinical trials. Optimization of Positive End-Expiratory Pressure might contribute to both prevention and treatment of PGD.
In this interventional single-center non-pharmacological study (with medical device), in the immediate postoperative period of patients who are undergone LuTX, we will evaluate the effects of varying levels of PEEP upon: - lung and chest wall mechanics, - intrapulmonary shunt fraction; - distribution of ventilation and perfusion; - gas exchange.
The final aim is to find the optimal level of PEEP in this patient's cohort
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Recipient of LUTX
- •Age > 18 years
- •Signed informed consent
排除标准
- •Age < 18 years
- •Already undergone LUTX
- •Major hemodynamic instability along the 24 hours following LUTX: systolic arterial pressure < 90 mmHg and/or heart rate > 120 beat/min and/or high dose vasopressor requirement (norepinephrine > 0.3 mcg/kg/min and/or epinephrine > 0.2 mcg/kg/min and/or dobutamine > 8mcg/kg/min)
- •Documented post-LUTX endobronchial plasma leak requiring high levels of PEEP > 15 cmH2O
结局指标
主要结局
Lung Compliance
时间窗: Measurements at three PEEP levels during a decremental PEEP trial
Identifying the level of PEEP associated to the best compliance
次要结局
- Intrapulmonary shunt(Measurements at three PEEP levels during a decremental PEEP trial)
- Lung collapse&overdistension(Measurements at three PEEP levels during a decremental PEEP trial)
- Dead space(Measurements at three PEEP levels during a decremental PEEP trial)
- Lung perfusion(Measurements at three PEEP levels during a decremental PEEP trial)
研究者
Giacomo Grasselli
Professor
Policlinico Hospital