Brain Oxygenation During Prehospital Anesthesia: an Observational Study (The BOPRA Study)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,300
- 试验地点
- 6
- 主要终点
- Favorable neurological outcome
研究概览
简要总结
Brain oxygenation of adult patients undergoing prehospital emergency anesthesia is monitored using noninvasive near-infrared spectroscopy. Patients are afterwards interviewed to define neurological outcome to measure quality of life. The purpose of this study is to reveal the risk factors of prehospital anesthesia related cerebral desaturation events (CDE) and to define the association between CDE and survival, neurological outcome or quality of life.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •sedation or anesthesia provided to facilitate endotracheal intubation, performed by Helicopter Emergency Medical Services (HEMS) team regardless of the reason
排除标准
- •Ongoing cardiopulmonary resuscitation at the time of intubation
- •Physical barrier for near-infrared spectroscopy measuring (e.g. forehead laceration)
- •HEMS unit does not escort patient to the hospital (exception: in case of death on scene after inclusion, patient is included)
- •Workload too high to ensure standard level of clinical care during the study
- •For interviews: no competence in Finnish, Swedish or English
结局指标
主要结局
Favorable neurological outcome
时间窗: 30 days
modified Rankin scale ≤2 (scale 0-6, 0 asymptomatic, 6 expired)
Cerebral desaturation event
时间窗: through prehospital care, approximately 60 minutes
an absolute drop of forehead cerebral saturation ≥ 10% from baseline for ≥ 5 minutes
次要结局
- 15D score(1 year)
- Survival(365 days)
- Favorable neurological outcome(1 year)
研究者
Jouni Nurmi, MD
associate professor
Helsinki University Central Hospital