Assessment of Loxapine in the Management of Restlessness During Mechanical Ventilation Weaning
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Weaning period
研究概览
简要总结
This study aims to assess the efficacy of a drug (loxapine, a neuroleptic) in calming patients down in a situation of restlessness during mechanical ventilation weaning. This drug is used for several years to quieten restless patients. Its purpose is to restore spontaneous breathing sooner and therefore to reduce the risks of intubation and mechanical ventilation.
详细描述
This study aims to assess the efficacy of a drug (loxapine, a neuroleptic) in calming patients down in a situation of restlessness during mechanical ventilation weaning. This drug is used for several years to quieten restless patients. Its purpose is to restore spontaneous breathing sooner and therefore to reduce the risks of intubation and mechanical ventilation. 300 patients will participate in the study and will be randomized, after informed consent, to receive either loxapine or a placebo.Patients whose proxies refuse participation will be sedated according to standard care procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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 ≥ 18 years,
- •under mechanical ventilation through intubation probe for more than 48 hours
- •no contra-indication to naso-gastric probe- with criteria for potential weaning
- •with social security
- •important restlessness at sedation withdrawal, defined as RASS score (Richmond Agitation Sedation Scale)=
- •This restlessness has no potential danger for the patient but requires a level of sedation. This re-sedation implies administration of morphinomimetics and benzodiazepines at dosages that does not allow to pursue mechanical ventilation weaning attempts.
排除标准
- •extreme restlessness at sedation withdrawal ((RASS>2)
- •allergy to loxapine or one of its component
- •dopaminergic agonists
- •extubation planned in the following 24 hours
- •antecedent of comitiality
- •known pregnancy at admission
- •proxies opposed to study participation
研究组 & 干预措施
loxapine
loxapine
干预措施: loxapine (Drug)
Placebo
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Weaning period
时间窗: up to 28 days
Weaning period (days) between inclusion (ie first administration of loxapine/placebo) and successful extubation (no re-intubation in the following 48 hours)
次要结局
- mortality rate(day 14 and week 6)
- total duration of mechanical ventilation(up to 28 days)
- incidence of unexpected extubations(up to 28 days)
- clinical and biological respiratory parameters(24 hours)
- incidence of mechanical ventilation related complications(up to 48 hours after extubation)
- incidence of adverse events, related and non related to the treatment(up to 28 days)
- factors associated to weaning failure(up to 28 days)