Brain Oxygenation During Prehospital Anesthesia: an Observational Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Disturbance-free time of the total monitoring time
研究概览
简要总结
The study will evaluate the feasibility of Nonin SenSmart H500 device to measuring brain oxygenation during prehospital anesthesia of adult patient. The study also estimates the incidence of cerebral hypoxic events of anesthetized patients during prehospital care. The study does not affect the treatment of the patient. The study is pilot study and will be followed with a main study to assess the association between cerebral oxygenation during prehospital care and outcome of the patient.
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 HEMS team regardless of the reason
排除标准
- •Cardiac arrest at the time of intubation
- •Physical barrier for NIRS measuring (e.g. forehead laceration)
- •HEMS physician does not escort patient to the hospital (and patient is not dead on the scene after inclusion)
- •Workload too high to ensure standard level of clinical care during the study
- •Known special vulnerability including known mental disability (permanent, not related to acute condition), patients in nursing homes, prisoners and forensic psychiatric patients.
- •Known or evident pregnancy
结局指标
主要结局
Disturbance-free time of the total monitoring time
时间窗: Prehospital phase
Proportion of time with readable monitor signal of the total time monitor connected to the patient
Cerebral desaturation events
时间窗: During prehospital phase after induction of anesthesia
Number of patients with forehead regional oxygen saturation ≤50% for ≥5 minutes
次要结局
- On-scene time(Prehospital phase)
- Neurologic disability(30 days, 12 months)
- Health related quality of life(12 months)
- Qualitative feedback from HEMS crews(Prehospital phase)
- Survival(30 days, 12 months)
研究者
Jouni Nurmi, MD
senior HEMS physician, associate professor
Helsinki University Central Hospital