A Single Center Pilot Study for Cold Oxygen Lung Preservation and Ventilation With the "Angel Cooler"
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Proportion of Devices Deemed "Functional"
研究概览
简要总结
The objective of this feasibility study is to evaluate continuous temperature monitoring, oxygen (O2) concentration and ventilation with positive end expiratory pressure (PEEP) to keep lungs cooled at 4-8 degrees Celsius, with continuous O2 concentration of 100% and inflated with a PEEP of 8-10 during the entire cold ischemic period.
详细描述
The Angel Lung Cooler is a lung preservation method for transplantation. The device has temperature and airway pressure sensors that assess the oxygen temperature in the airways to confirm during the entire preservation time that desired airway temperatures (between 8 and 10 oC) and mean airway pressure to keep the lungs inflated during transportation is optimized.
For the purposes of the trial, the Angel Cooler will be in the operating room at time of transplant when both of the lungs are explanted. The explanted lungs (those removed and not the donor lungs) will be connected to the cooler to determine inflation and temperature changes of the lungs. This procedure will take approximately 5 - 20 minutes. The lungs will then be disconnected from the cooler and then returned to the back table for transport to the Pathology department. As part of standard procedures, the lungs remain in the Operating room for a few hours before they are transported to the Pathology department.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 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
- •Age at least 18 years
- •Subjects who have signed Universal Consent are eligible for participation.
- •Subjects willing to sign the Universal Consent for the use of their lungs in this study.
排除标准
- •Explanted lungs of those who have not signed the Universal Consent (UC) or who have declined participation in the UC will be excluded.
结局指标
主要结局
Proportion of Devices Deemed "Functional"
时间窗: Day 1
The main outcome is a description of the function of the device (functional/non-functional).
次要结局
未报告次要终点
