Is a Rigid Fiberscope With a Flexible Tip Superior to Standard Flexible Fiberoptic Intubation: a Prospective Multicentre Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 4
- 主要终点
- Time (seconds) to successful orotracheal intubation during the first successful attempt.
研究概览
简要总结
The purpose of the study is to compare first attempt success rates and time until intubation to establish the learning curves of the participating anaesthesiologists with two different intubation strategies: (Karl Storz C-MAC VS (Video Stylet) and the standard flexible intubation video endoscope at the study site.
详细描述
The intubation of the trachea is a crucial procedure in anaesthesia and emergency medicine, therefore it is considered as one of the core competences in these disciplines. Novices in the field need to learn intubation fast and without harming patients to ensure a patent airway if needed.
According to the European Union of Medical Specialists (U.E.M.S., 1050 Brussels, BE), every anaesthesiologist has to master different techniques for the airway management. One is the fiberoptic intubation in awake or asleep patients, to manage a difficult airway. For further training, these core competences need to be extended during the career, from level A (has knowledge) to level D (teaches or supervises others). As the intubation with flexible fiberoptic scopes is the gold standard for the management of a known difficult airway, the investigators want to compare this to a new technique. The use of flexible scopes do not guarantee easy intubation in every difficult airway situation and intubation sometimes is difficult to achieve and requires high proficiency (unability to steer, unability to overcome an anatomical obstacle). Various approaches were introduced by the medical device industry to overcome that problem. One new device is a rigid video stylet with a flexible tip (Karl Storz C-MAC VS), which is an advancement of the older rigid scope "Bonfils" (Karl Storz).
Intubation training with the Bonfils stylet has been shown to require about 20 consecutive tracheal intubations by novices to reach expert time. Learning curves for fiberoptic intubations seem to be similar, but a greater variance was observed. A study of the investigators research-group (unpublished data, KEK 247/09), comparing learning curves between the rigid fiberoptic Bonfils and the semi-rigid fiberoptic SensaScope suggested a 90% success rate for intubation within 60 seconds after about 15 trials (Bonfils) and 20 trials (SensaScope). In comparison, there is no validated data for the use of rigid scopes with flexible tips, as these tool are very new.
Video stylets are tools originally designed for difficult airway management as well. The C-MAC VS combines rigid and semi-rigid abilities. Intubation seems to become very easy. But yet, there is no data available which proves that assumption. Thus the study wants to evaluate if intubation success and time is superior with the C-MAC Video Scope compared to the difficult intubation gold standard, the intubation with a standard flexible fiberoptic scope.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Anaesthesiologists starting in the respective anaesthesia department who are not experienced with tracheal intubation with the study devices
- •Informed Consent as documented by signature (Appendix Informed Consent Form)
- •Novice to the C-MAC VS
- •No/few fiberoptic oral asleep intubation experience (max. 5x during the last year)
排除标准
- •More than 5 uses during the past year of either one of the study devices
- •Not available at the study site during entire study (expected drop outs)
- •Not able to fill out English case reports
- •Patients: Planned delayed extubation (e.g. planned transfer to ICU)
结局指标
主要结局
Time (seconds) to successful orotracheal intubation during the first successful attempt.
时间窗: Start: Device passes patients lips; End: Device is completely removed out of the tracheal tube (a trial consists of a maximum of 2 intubation attempts, each with a maximum duration of 120 seconds)
With the C-MAC VS and the standard flexible scope
次要结局
- Number of intubation attempts(Start: Device passes patients lips; End: Device is completely removed out of the tracheal tube (trial in total not >240 seconds))
- Subjective difficulty of the intubation procedure(Start: Device passes patients lips; End: Device is completely removed out of the tracheal tube (trial in total not >240 seconds)
- Patients vital parameter such as heart rate, during the intubation attempt(Start: Device passes patients lips; End: Device is completely removed out of the tracheal tube (trial in total not >240 seconds))
- Overall time from startpoint to glottic view(It cannot be longer than 240 seconds and is defined for unsuccessful trials, i.e. if no intubation was established, as 360 seconds.)
- Cormack/Lehane grade(Start: Device passes patients lips; End: Device is completely removed out of the tracheal tube (trial in total not >240 seconds))
- Patients demographic data such as age(During the process of screening, up to 24 hours before the study session starts)
- Time to first end expiratory CO2 reading(Start: Device passes patients lips; End: First end expiratory CO2 reading (trial in total not >240 seconds))
- Correlation to patients' anatomical characteristics(Start: Device passes patients lips; End: Device is completely removed out of the tracheal tube (trial in total not >240 seconds))
- Participants characteristics and demographic data(Before the study session starts (up to 24 hours before the first intubation attempt))
- Patients demographic data such as weight(During the process of screening, up to 24 hours before the study session starts)
- Limited or restricted vision through the devices (either C MAC VS or a standard flexible scope)(Start: Device passes patients lips; End: Device is completely removed out of the tracheal tube (trial in total not >240 seconds))
- Patients vital parameter such as blood pressure, during the intubation attempt(Start: Device passes patients lips; End: Device is completely removed out of the tracheal tube (trial in total not >240 seconds))
- Patients vital parameter such as oxygen saturation, during the intubation attempt(Start: Device passes patients lips; End: Device is completely removed out of the tracheal tube (trial in total not >240 seconds))
- Patients demographic data such as ASA risc classification (ASA= American Society of Anaesthesiologists)(During the process of screening, up to 24 hours before the study session starts)
- Patients demographic data such as height(During the process of screening, up to 24 hours before the study session starts)
- Patients demographic data such as gender(During the process of screening, up to 24 hours before the study session starts)