NCT01995292已完成不适用
Comparative Clinical Trial of Conventional and Modified "Spray as You go" Technique With the "Enk Fiberoptic Atomizer Set" for Awake Fiberoptic Intubation (Atomizer Study)
Johannes Gutenberg University Mainz2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2013年10月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Comfort evaluation by the patient
研究概览
简要总结
The purpose of this study is to determine whether modified "spray as you go" technique using the Enk Fiberoptic Atomizer Set during awake fiberoptic intubation is more comfortable for the patient.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
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
- •Age ≥18 years
- •no concurrent participation in another clinical trial
- •German language in speaking and writing
- •Capability of giving consent
- •written informed consent
- •an elective surgery under general anesthesia, in which an awake fiberoptic intubation is indicated
排除标准
- •Age < 18 years
- •pregnant women
- •patients unwilling or unable to give informed consent
- •ASA classification > 3
- •Known allergy to local anesthetics
- •Participation in another clinical trial
研究组 & 干预措施
bronchoscope
Experimental
Patients will receive local anaesthetics via the working channel of the bronchoscope.
干预措施: bronchoscope (Device)
Enk Fiberoptic Atomizer
Experimental
Patients will receive local anaesthetics for the awake fiberoptic intubation via the Enk Fiberoptic Atomizer.
干预措施: Enk Fiberoptic Atomizer (Device)
结局指标
主要结局
Comfort evaluation by the patient
时间窗: up to 4 weeks
Comparison of conventional and modified "spray as you go" technique
次要结局
- Comfort evaluation by the present nurses(up to 4 weeks)
- Comfort evaluation by the performing as well as assisting anesthetist(up to 4 weeks)
- Patient response (coughing, gagging, grimacing, defenses)(up to 4 weeks)
- Vital signs(up to 4 weeks)
研究者
Nina Pirlich, Dr. med.
Dr. med. Nina Pirlich
Johannes Gutenberg University Mainz
研究点 (2)
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