Dexmedetomidine for Non-invasive Ventilation After Chest Trauma (VENDETTA)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Duration of NIV session
研究概览
简要总结
Crossover randomized controlled double blinded trial :
- The primary endpoint is the duration of Non Invasive Ventilation (NIV) session (minutes) with dexmedetomidine (DEX) or placebo.
- Secondary endpoints will be the sedation level as assessed by the Richmond Agitation Sedation Scale (RASS), the number of interventions to allow the completion of NIV session, the pain intensity level as assessed by visual analogue scale, the morphine and ketamine consumption during NIV sessions, the comparison of blood gas measurements before and after NIV sessions, the reproducibility of NIV cycles. The side effects of DEX will be notified.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, 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
- •Blunt chest trauma with thoracic trauma score> 6, ICU admission and spontaneous breathing
排除标准
- •Contra indication for NIV or Dexmedetomidine as specified by the French marketing authorization
研究组 & 干预措施
Placebo
Sodium Chloride 0,9 % Continuous IV infusion begun one hour before NIV session at 0.07 ml/kg/h Adaptation to sedation status by changing infusion speed of 0.02 ml/kg/h every 30 minutes up to 0.14 ml/kg/h Sedation objective Richmond Agitation Sedation Scale -3 (moderate sedation) to 0 (alert and calm)
干预措施: Placebo (Drug)
DEX
Dexmedetomidine diluted to 10 µg/ml in Sodium Chloride 0,9 % Continuous IV infusion begun one hour before NIV session at 0.7 µg/kg/h (= 0.07 ml/kg/h) Adaptation to sedation status by changing infusion speed of 0.2 µg/kg/h (= 0.02 ml/kg/h) every 30 minutes up to 1.4 µg/kg/h (= 0.14 ml/kg/h) Sedation objective Richmond Agitation Sedation Scale -3 (moderate sedation) to 0 (alert and calm)
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
Duration of NIV session
时间窗: During ICU stay (expected average of 2 weeks)
Minutes
次要结局
- Richmond Agitation-Sedation Scale(During ICU stay (expected average of 2 weeks))
- Number of interventions on NIV settings(During ICU stay (expected average of 2 weeks))
- Variation of arterial partial pressure of dioxygen (O2) before and after NIV session(During ICU stay (expected average of 2 weeks))
- Morphine consumption(During ICU stay (expected average of 2 weeks))
- Ketamine consumption(During ICU stay (expected average of 2 weeks))
- Pain visual analogue scale(During ICU stay (expected average of 2 weeks))
- Variation of arterial partial pressure of Carbon dioxide (CO2) before and after NIV session(During ICU stay (expected average of 2 weeks))
- Variation of potential hydrogen (pH) before and after NIV session(During ICU stay (expected average of 2 weeks))
- Reproductibility of NIV sessions(During ICU stay (expected average of 2 weeks))
- Bradycardia(During ICU stay (expected average of 2 weeks))
- Hypotension(During ICU stay (expected average of 2 weeks))