Ketamine Efficacy for Acute Severe Bronchospasm in Mechanically Ventilated-critically Ill Patients: a Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- bronchospasm improvement
研究概览
简要总结
Despite few scientific evidence that could support the use of ketamine in adult patients undergoing acute bronchospasm requiring mechanical ventilation (MV), ketamine is largely employed in this setting. The aim of this study is therefore assess more definitively the real benefit of using ketamine in patients with severe bronchospasm, requiring ICU stay and need for MV in order to establish or refute the use of this drug as "standard therapy" in these cases.
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 (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •patients with acute exacerbation of COPD or status asthmaticus, undergoing controlled mechanical ventilation
- •acute bronchospasm, defined as airway resistance value (Rsr max) greater than 12, use of inhaled therapy with bronchodilators and systemic corticosteroids
- •patients requiring the use of continuous intravenous sedation for optimization of ventilation
排除标准
- •contraindication or history of previous adverse events with the use of the studied drugs
- •other diagnostic potential Rsr increase of not causing bronchospasm (bronchial obstruction, acute respiratory distress syndrome adult, pulmonary fibrosis)
研究组 & 干预措施
Ketamine
Intravenous ketamine infusion: bolus 2mg per kg and continuous infusion (2mg/kg/h)
干预措施: Ketamine (Drug)
Fentanyl
Fentanyl: bolus infusion 1μg per kg and continuous infusion (1μg/kg/h)
干预措施: Fentanyl (Drug)
结局指标
主要结局
bronchospasm improvement
时间窗: 3 hours post beginning of drug infusion
Maximal airway resistance reduction in hour 3-post beginning of drug infusion
次要结局
- Time to weaning(Time (in days) to first spontaneous breathing trial post randomization up to 28 days)
- bronchospasm improvement(24 hours post beginning of drug infusion)
研究者
Wagner Luis Nedel
MD, MSc.
Hospital Nossa Senhora da Conceicao