Comparison of Two Strategies to Realize Apnea Test for the Diagnostic of Brain in Potentiel Organ Donors.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 208
- 试验地点
- 17
- 主要终点
- Eligibility to 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 with little patients,. That why the aim of the present study is to compare the standard strategy and CPAP strategy with a prospective, multicenter,cluster trial; each center will use the method of apnea test which it uses usually.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age : from 18 to 75 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 lung harvest
时间窗: 2 years
次要结局
- Rate of apnea test interruption(2 years)
- Number of lung transplantation realization(2 years)
- Levels of hypoxemia(2 years)
- Rate of cardiocirculatory impairment(2 years)
- Arterial blood gas after apnea test(2 years)
- Rate of ventilatory impairment(2 years)
