The Rigid Fiberscope With a Flexible Tip C-MAC®VS in the Real Anaesthesia World: A Clinical Observation of Intubation Success and Complications
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- First-attempt oro-tracheal intubation success rate in percentage
研究概览
简要总结
During orotracheal intubation failure in securing an airway can result in serious oxygenation problems.
Beside the classic laryngoscopes and fibreoptic scopes, devices with high-resolution video cameras placed in the tip of the devices, were developed and attained in daily routines. Studies and case reports reveal them to be superior in both normal and difficult intubation, especially improving the first-attempt success rate.
Latest advancements of the Bonfils fiberscope resulted in the C-MAC VS, which combines rigid and semi-rigid abilities to a rigid video stylet with a flexible tip. Because of its front positioned high-resolution camera resulting in an indirect visualization, it may also have the benefits of video laryngoscopes.
Very little data is available on larger numbers of use and the investigators do not know about rare side effects and complications with the use of the device, such as esophageal intubations. Due to its direct view and positioning on vocal cord level, the investigators expect a similar or even lower rate of endotracheal intubation, using the C-MAC VS.
The investigators therefore plan to analyze the use of the C-MAC VS regarding its efficiency and safety during airway management in everyday clinical practice. This should provide the evidence about safe use, possible risk factors, rare complications and adverse events, as well as the preferred clinical airway situations to use the C-MAC VS.
详细描述
Orotracheal intubation is a core competence in anesthesia and emergency medicine. Failure in securing an airway can result in hypoxemia, aspiration, neurologic damage, cardiovascular complications, and death. Difficult anatomic structures, upper airway abnormalities, or airway trauma bear the risk of failed intubation inability to ventilate the lungs that furthermore results in oxygenation failure.
Literature tells that the rate of unexpected difficult intubations ranges from 5 to 10%, mostly corresponding to a Cormack/Lehane grade (C&L) 3 or 4.
Beside the classic laryngoscopes and fibreoptic scopes, devices with high-resolution video cameras placed in the tip of the devices, were developed and attained in daily routines. Studies and case reports reveal them to be superior in both normal and difficult intubation, especially improving the first-attempt success rate.
Rigid fiber-optic scopes may reduce intubation time and their use may result in a higher success rate. A study with 216 Patients using the Bonfils fiberscope for airway management, showed a success rate up to 98,4. Looking at the complication rates, upper airway trauma in normal patients after direct laryngoscopy with a Macintosh blade has been reported up to 6.9% and can be reduced by using a video laryngoscope.
Latest advancements of the Bonfils fiberscope resulted in the C-MAC VS, which combines rigid and semi-rigid abilities to a rigid video stylet with a flexible tip. Because of its front positioned high-resolution camera resulting in an indirect visualization, it may also have the benefits of video laryngoscopes.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Patients for elective and emergency surgery who have at least one predictor for difficult airway management, which are: Mallampati score >2, mouth opening <4cm, thyromental distance <6cm, head & neck movements <90°, short neck, reduced reclination.
- •Patients who signed general research consent in Switzerland.
排除标准
- •Patients under the age of 18 years
- •Personnel at the study site not available of not sufficient ted in the device.
- •Expected impossible mask ventilation
- •High risk of aspiration (requiring rapid sequence induction intubation)
- •Intracranial surgery
- •Limited knowledge of German language or refusing general consent.
结局指标
主要结局
First-attempt oro-tracheal intubation success rate in percentage
时间窗: The overall rate of successful intubation at first attempt. The study will end when the tracheal tube is placed properly and the airway is secured (the first attempt should not pass 120 seconds)
Rate of a successful intubation at first attempt
次要结局
- Number of attempts(Intraoperative (Starts when the device is inserted in the patients mouth and ends when the airway is secured.))
- Intubation interim times(The interim times need to be as short as possible. The estimated time for intubation: 120 seconds.)
- Possible problems with C-MAC VS(If any problems occur during the preparations or during intubation itself which starts when the device is inserted in the patients mouth and ends when the airway is secured. Estimated time for intubation: 120 seconds)
- Difficulty of intubation(Starts when the device is inserted in the patients mouth and ends when the airway is secured. Estimated time: 120 seconds)
- Time of the intubation procedure(Starts when the device is inserted in the patients mouth and ends when the airway is secured. Estimated time: 120 seconds)
- Overall success rate(Intraoperative (The study will end when the tracheal tube is placed properly and the airway is secured.))
- Tube size used(Baseline)
- Preferred method used to lift the tongue ventral to increase space in the oral cavity and the approach(The beginning of the intubation procedure, when the device is inserted in the patients mouth. Estimated time 120 seconds)
- An alternative method to establish a patent airway(Starts when the device is inserted in the patients mouth and ends when the airway is secured. Estimated time for intubation: 120 seconds)
- Complications during intubation(Starts when the device is inserted in the patients mouth and ends when the airway is secured. Estimated time: 120 seconds)
- Airway ratings (Cormack- Lehane and POGO)(The ratings are made during the process of intubation, so when the the device is inserted in the patients mouth and ends when the airway is secured. Estimated time for intubation: 120 seconds)