Ex Vivo Lung Perfusion : Evaluating the Effect of Cellular Perfusate on Mechanical Properties and Gas Exchange Function of the Donor Lungs : A Randomised Cross Over Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Compliance
研究概览
简要总结
The lungs retrieved from the brain dead multi organ donor will be placed in a lab . They will be connected to a ventilator and preservative solution will be circulated through it . Blood will be added to the fluid depending on the group to which the lungs are allocated and its effects on lung function will be seen
详细描述
The lungs of a brain dead multi organ donor will be retrieved according to standard protocol. Once a decision is made not to transplant the lungs either because of not satisfying ideal criteria or in the absence of a potential recipient they will be included in the study.They will be ventilated optimally and connected to a cardiopulmonary bypass machine for circulating preservative solution through it . Red blood cells will be added to the solution either initially or later depending on the group to which it is allocated .Monitoring of mechanical and gas exchange function and pathological examination of the lungs will be performed at various time points to observe the effect of red blood cells. The lungs will be properly discarded at the end of the procedure and will not be used for transplantation.
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
- 16 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Brain death certified multi organ donor
- •Absence of ideal lung donor criteria or absence of suitable lung recipient
排除标准
- •presence of severe mechanical lung injury on visual inspection or radiography
- •Presence of pneumonia
- •Positive serology ( Hepatitis B,C and HIV
结局指标
主要结局
Compliance
时间窗: From beginning of perfusion to 4 hours after that
Measured from the airway pressure on ventilator
次要结局
- Partial pressure to Inspired oxygen concentration ratio(From beginning of perfusion to 4 hours after that)
- Pulmonary vascular resistance(From beginning of perfusion to 4 hours after that)
- Lung injury score(From beginning of perfusion to 4 hours after that)
研究者
Rajarajan Ganesan
Senior resident
Post Graduate Institute of Medical Education and Research, Chandigarh