NCT02570269已完成不适用
Prospective Randomized Comparison Between a Flexible Fiberoptic Intubation Via the Ambu® Aura Gain™ Airway and the Slotted Guedel Tubus in Terms of Time to a Completed Airway Management and Patient Safety.
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 94
- 试验地点
- 2
- 主要终点
- Intubation time
研究概览
简要总结
The study has to show that an intubation with the AuraGain Laryngeal mask could bring the same benefits in terms of intubation in clinical practice, as the slotted Guedel tubus.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, 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
- 是
入选标准
- •Surgery of the shoulder, elbow, hand, hip, knee or foot
- •Signed consent form
排除标准
- •Patients with expected difficulties regarding to the intubation
- •Patients with diseases / anatomical changes in the area of the pharynx, the larynx, the trachea, the esophagus or the stomach
- •Not sober
- •Increased risk of aspiration
- •BMI > 35 kg/m2
- •Acute disease which could affect the suitability of the anesthesia
- •Patients in which the use of a laryngeal mask is contraindicated or otherwise not possible
- •Patients with a disease which prevents an accurate examination of the patients (eg neuromuscular, mentally, metabolic disease)
- •Drug abuse in the recent past
- •Legal incompetence
研究组 & 干预措施
AuraGain
Active Comparator
The patient will get a fiberoptic Intubation via the AuraGain larynxmask
干预措施: AuraGain (Procedure)
Slotted Guedeltubus
Placebo Comparator
The patient will get a fiberoptic intubation via the slotted Guedeltubus
干预措施: Slotted Guedeltubus (Procedure)
结局指标
主要结局
Intubation time
时间窗: Intraoperative
Time to complete the Intubation in seconds
次要结局
- Esophagal Intubation attempts(Intraoperative)
- Pain after Intubation as assessed by a Numeric Rating Scale(Intraoperative/2h postoperative/24h postoperative)
- AE/Complications(Intraoperative/postoperative until 24h)
- Intubation attempts(Intraoperative)
- Position of the mask as assessed by the Brimacombe Score(Intraoperative)
- Resistance measurement of the Insertion as assessed by a four point scoring system(Intraoperative)
研究者
Berthold Moser
Principal Investigator
Schulthess Klinik
研究点 (2)
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