Prospective Evaluation of Volatile Sedation Management in Critical Care After Free Flap Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Working time expenditure
研究概览
简要总结
Patients undergoing complex free flap surgery are randomised to volatile or intravenous sedation in terms of subsequent intensive care sedation, based on the in-hospital standard of care. For study purposes, differences in management (set-up times, change of filters, etc.) will be investigated in relation to accelerated awakening and possibly improved neurocognition after the end of sedation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Free flap surgery
- •Patient capable of giving informed written consent
排除标准
- •Intolerance to volatile anaesthetics (e.g. malignant hyperthermia).
- •Severe obstructive pulmonary disease
- •Pre-existing severe neurocognitive disorder
- •Age <18 years (minors)
结局指标
主要结局
Working time expenditure
时间窗: Inventory of the required time until the end of sedation (90 hours)
Time spent by nurses or physicians on the specific sedation procedure, as well as the corresponding financial value based on nationally applicable collective wage agreements in euros or US dollars.
Material consumption
时间窗: Inventory of the required materials until the end of sedation (90 hours)
Required equipment and disposable materials related to the treatment interval as well as their monetary value in euros or US dollars.
次要结局
- Time to awake(Within the intensive care stay (5 days))
- Delir(Within the intensive care stay (5 days))
研究者
Armin N. Flinspach
Principal Investigator
Goethe University