NCT01632085Unknown不适用
Comparison of Two Laryngoscopes: Single-use Device Laryngobloc ® (SU) Versus Reusable Handle With Disposable Metal Blade (R) : Quality of Laryngoscopy and Bacterial Contamination of the Handle
University Hospital, Strasbourg, France2 个研究点 分布在 1 个国家目标入组 480 人开始时间: 2012年6月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 480
- 试验地点
- 2
- 主要终点
- The quality of laryngoscopy
研究概览
简要总结
Reduce the risk of nosocomial transmission of germs related to the reusability of the laryngoscope handle. The alternative is to replace it with a disposable device, provided that it is as effective as the reference strategy at a reasonable cost.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Men or women over 18 years·
- •Hospitalized for elective surgery and targeted for orotracheal intubation under direct laryngoscopy under general anesthesia with neuromuscular blockade resolved·
- •Subject has signed informed consent·
- •Suject affiliated to a social protection·
- •Subject informed of the results of medical examination
排除标准
- •Contraindication to general anesthesia or one of its components·
- •General anesthesia without a competitive muscle relaxant·
- •Patient with criteria for difficult intubation·
- •Patient targeted for special care of the airway (fiberoptic or vidéolaryngoscopy), whatever the indication as Mallampati class 4·
- •Subject in class 4 Mallampati·
- •Acts performed in the emergency setting·
- •Pregnancy and obstetric procedures·
- •Breastfeeding·
- •Difficulty in communication with the patient (including obtaining informed consent, evaluation of pain in the recovery Room ·
- •Subject in exclusion period (determined by a previous study or a study in progress)
结局指标
主要结局
The quality of laryngoscopy
时间窗: 1 year
The quality of laryngoscopy. The quality of the visibility of the glottis, is assessed by the Cormack and Lehane grade. A rank of 1 or 2 will be considered a success for the analysis of results.
次要结局
- Evaluation microbiological and evaluation of intubation(1 year)
研究者
研究点 (2)
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