Comparison of Two Strategies to Realize Apnea Test for the Diagnostic of Brain Death in Potential Organ Donors (CPAPNEE STUDY)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 208
- 试验地点
- 26
- 主要终点
- Eligibility to donor lung harvest
研究概览
简要总结
Clinical diagnostic of brain death requires a non-reactive coma, absence of brain stem reflex, and absence of spontaneous breathing. The confirmation of absence of spontaneous breathing is established the apnea test (according to the American Academy of Neurology's Guidelines). However this test may lead to complications (acute hypoxemia, ventilatory and cardiocirculatory disorders) and reduces significantly the number of lung transplants. Some data suggest modifying the apnea test : replace the ventilator switching off with continuous positive airway pressure (CPAP) use. These studies showed that this alternative method (CPAP) increased the level of lung harvest but they were not sufficient because these studies were monocentric, non randomized and with little patients,. That why the aim of the present study is to compare the standard strategy and CPAP strategy with a prospective, multicenter, randomized study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age : from 18 to 70 years
- •Neurological signs evoking cerebral ischemia
排除标准
- •Severe hypoxemia (PaO2/FiO2 < 200) with controlled ventilation (FiO2: 100%)
- •Hypothermia < 36°C
- •Obesity (BMI ≥ 40) with documented hypopnoea
- •Intractable hypotension despite optimal filling and catecholamine doses > 1µg.Kg.min
- •Patients with contraindication for organs harvesting.
- •Documented chronic respiratory failure
- •Progressive infectious acute respiratory disease
- •Family opposition to subject's participation in the study
结局指标
主要结局
Eligibility to donor lung harvest
次要结局
- Number of lung transplantation realization
- Rate of cardiocirculatory disorder
- Level of hypoxemia
- Rate of ventilatory disorder
- Rate of apnea test interruption
- Arterial blood gas after th apnea test
