中文摘要

研究背景：

“无法插管，无法氧合”（Can’t Intubate, Can’t Oxgenate, CICO）紧急气道是每一位麻醉医师在临床工作中最为不愿面对的危机状况，判断失误、决策延迟和营救技能缺乏是导致灾难性后果的直接原因。因而，麻醉医师需要掌握多种困难气道管理技术，以利于在困难气道处理中，当一种气道管理技术失败后，能够快速选择另一种可行技术，从而更加有效预防/避免严重威胁患者生命安全的CICO紧急气道发生。Cookgas气管插管型喉罩的构造及其配套工具的改进，使其可能会在困难气道维持、困难气管插管处理，特别是重度困难气管插管处理中发挥更加突出的重要作用，从而可为麻醉医师处理重度困难气管插管提供可借鉴的有效管理方法，切实预防CICO紧急气道的发生。同时，环甲膜穿刺、切开术作为营救CICO紧急气道、挽救患者生命的最后选择，需要每一位麻醉医师熟练掌握，并能够在CICO危急时刻快速、有效地实施。然而，目前国内缺乏相关系统、完备的培训资料，更是缺乏规范、定期开展的“紧急气道管理”模拟教学培训。故此，在困难气道管理领域，如何有效开展紧急气道管理模拟教学培训还需要进一步探索和研究。

研究目的：

评价Cookgas和Fastrach插管型喉罩在重度困难气管插管处理中应用的可行性和安全性，验证Cookgas喉罩引导重度困难气管插管的成功率优于Fastrach喉罩。

了解国内麻醉医师对环甲膜穿刺、切开技术的掌握情况；整理和编写环甲膜穿刺、切开术技能培训资料；研究设计简易环甲膜穿刺、切开术教学培训模型；建立适宜的环甲膜穿刺、切开技术培训模式和评估体系。

研究方法和结果：

第一部分：解决重度困难气管插管新技术的临床研究

方法：择期在全身麻醉下行整形外科手术的预测重度困难气管插管患者（同时具有甲颏距离＜60 mm；张口度＜35 mm；Mallampati分级Ⅲ级或Ⅳ级）60例，随机分为Cookgas喉罩组（n=30）和Fastrach喉罩组（n=30）。麻醉诱导后，经口置入喉罩，获得喉罩最佳通气位置后，采用纤维光导支气管镜（Fibreoptic Bronchoscope FOB）经喉罩寻找声门，并引导完成气管插管。主要观察指标是喉罩置入和FOB引导气管插管成功与否，以及成功插管的次数和所用时间。整个研究期间不符合随机对照研究标准，但又考虑应用喉罩处理的重度困难气管插管病例，根据患者气道评估结果，麻醉医师自行决定喉罩使用类型，包括Cookgas喉罩、Fastrach喉罩和CTrach喉罩,并对其进行注册登记，收集气管插管的全部信息。

结果：Cookgas喉罩组30例患者和Fastrach喉罩组27例患者成功置入喉罩，在3例Fastrach喉罩置入失败患者，改用Cookgas喉罩成功完成喉罩置入；Cookgas喉罩组26例患者FOB引导首次气管插管成功，4例患者在第2次成功插管。在成功置入Fastrach喉罩的27例患者中，有20例FOB引导1次插管成功，4例2次成功，3例失败，改置入Cookgas喉罩后，2例由FOB引导首次插管成功，1例第2次成功插管。与Cookgas喉罩组比较，Fastrach喉罩组喉罩置入时间显著延长。

在注册研究的21例患者中，7例患者采用Cookgas喉罩联合FOB和8例患者采用Fastrach喉罩联合FOB引导气管插管，6例患者采用CTrach喉罩完成气管插管。Cookgas组有5例患者张口度小于15mm，其中最小张口度为11mm；Fastrach组和CTrach组患者的最小张口度为15mm。三组喉罩首次置入成功率差异无统计学意义,但Fastrach组和CTrach组喉罩置入时间明显长于Cookgas组。

第二部分：紧急气道管理的模拟教学培训

方法：利用手机微信平台制作调查问卷，用以了解国内麻醉医师对环甲膜穿刺、切开技术的掌握情况。通过大量查阅文献及相关资料，联合解剖学专家、三维动漫及教学录像制作专家整理制作“环甲膜穿刺、切开术教学培训”录像和模拟教学培训评估量表。利用简单材料设计制作经济、适用的环甲膜穿刺、切开术训练模型。开展紧急环甲膜切开术模拟教学培训，在培训前、理论授课后、模拟操作培训后分别通过调查问卷形式了解学员对相关知识的掌握情况和实施操作的自信度，两位评委根据学员在理论授课后和模拟操作培训后的操作技能考核录像分别对学员进行环甲膜切开术操作步骤评分和整体操作评估。

    结果：445份有效调查问卷显示，近60％麻醉医生对环甲膜局部解剖知识不了解；能够熟练掌握环甲膜穿刺、切开技术的麻醉医生不足10％；超过65％的麻醉医生没有接受过环甲膜穿刺、切开术技能培训。参考借鉴英国困难气道协会2015年颁布的非预料的成人困难气管插管管理指南，精心制作时长约30分钟的“环甲膜穿刺、切开术教学培训”录像，涵盖环甲膜局部解剖三维动漫演示，紧急环甲膜穿刺、切开操作技术详细讲解，简易环甲膜穿刺、切开术训练模型制作方法以及实施紧急环甲膜穿刺、切开术必须掌握的相关知识。设计制作的环甲膜穿刺、切开术训练模型获得了国家实用新型专利。通过开展紧急环甲膜切开术模拟教学培训，建立和完善了适宜的环甲膜穿刺、切开技术培训模式和评估体系。结果表明：与培训前和理论授课后相比较，学员在模拟操作培训后对实施环甲膜切开术相关知识的掌握情况和自信度显著提高，并且实施环甲膜切开术的操作步骤评分和整体操作评估均明显提高。

研究结论：

Cookgas喉罩和Fastrach喉罩联合FOB均可安全、有效地应用于预测重度困难气管插管患者，但在重度面颈瘢痕挛缩和/或颈部置有巨大扩张器患者，Cookgas喉罩置入和辅助FOB引导气管插管的成功率优于Fastrach喉罩。

Cookgas、Fastrach和CTrach三种插管型喉罩均可安全、有效地应用于预测重度困难气管插管患者，但对于张口度小于15mm和/或颈部瘢痕重度挛缩或颈部置有巨大扩张器的患者，Cookgas喉罩具有明显优势。

非常有必要对麻醉医师开展环甲膜穿刺、切开术技能培训，绝大多数麻醉医师迫切希望接受紧急气道管理技能培训。

精心制作的环甲膜穿刺、切开术教学培训录像和训练模型满足了紧急气道管理技能培训的教学需要。

模拟操作培训显著提高学员实施环甲膜切开术的相关理论知识、操作技能和自信度。

Background:

“Can’t Intubate, Can’t Oxygenate (CICO)” emergency airway is the crisis situation which no anesthesiologist would like to face it in the clinical work.The false judgment,the delayed decision,and the lack of rescue skills directly contribute to the disastrous consequences.The anesthesiologists need to master a variety of difficult airway management techniques in order to deal with difficult airways,even though one sort of technology failed, another feasible technology can be selected quickly. So, it can effectively prevent/avoid the occurrence of the CICO emergency airway which will seriously threaten the patients’ safety. Cookgas intubating laryngeal airway (CILA) has lots of improvements in the structure and accessories, that can make it play an important role in ventilation maintenance of difficult airway, difficult intubation management, especially in the management of severe difficult endotracheal intubation. CILA may provide the referential effective method for the anesthesiologists to manage the severe difficult endotracheal intubation, eventually prevent the happening of CICO emergency airway. In addition, cricothyrotomy acts as the final effective choice for rescuing the CICO emergency airway and saving patients’lives. It is necessary to let all of the anesthesiologists skillfully master the cricothyrotomy, so that they are able to implement quickly and effectively in crisis times of CICO. However, so far, there are not only the lack of appropriate training materials, but also the emergency airway management simulation training that are carried out regularly and termly in China. Therefore, in the area of difficult airway management, how to effectively carry out emergency airway management simulation training is still need further study.

Objective:

To evaluate the feasibility and safety of Cookgas intubating laryngeal airway (CILA) and the Fastrach intubating laryngeal mask airway (FT-LMA) in serious anticipated difficult airways. To verify the intubation successs rate of CILA is higher than Fastrach’s in guiding serious predicted difficult oraltrachel intubation.

To investigate the knowledge, skill and confidence of Chinese anesthesiologists on performing cricothyrotomy; To collect and collate the the teaching materials for training the lifesaving procedure, cricothyrotomy; To design a simple inexpensive model for the skill training of cricothyrotomy; Furthermore, to establish the appropriate teaching method and evaluation system of cricothyrotomy training.

Methods and Results:

Part One：The clinical study of the new technique deals with difficult oraltrachel intubation

Methods: Sixty healthy patients with all of three difficult intubation criterion (thyromental distance ＜60 mm, opening mouth distance ＜35mm and Mallampati class Ⅲ or Ⅳ）who were undergoing elective plastic surgery under general anesthesia were randomly allocated into CILA group (n=30) and FT-LMA group (n=30). After anesthesia being induced and CILA or FT-LMA being inserted, the patients were treated with FOB-guided intubation through CILA or FT-LMA. The success of the intubating laryngeal airway（ILA）insertion and FOB-guided intubation, the number of attempts and duration of the successful attempt were recorded. The patients with serirous predicted difficult airways did not meet the inclusion / exclusion criteria, but needed to be intubated with ILA. The types of the ILA were chosen by the anesthesiologists according to the airway evaluation results of patients and their favorite tools. These cases belonged to registry study and all of intubation information was collected during the study period.

Results: In randomized controlled trial (RCT), the ILA was inserted successfully in 30 patients of CILA group and 27 ones of FT-LMA group. 3 failed cases in FT-LMA group were inserted successfully with CILA. In CILA group, the first FOB-guided intubation attempt succeeded in 26 patients, 4 cases were intubated at the second attempt. In 27 patients of FT-LMA group, 20 cases were intubated successfully at the first attempt, 4 at the second attempt, and 3 cases failed, two of them were intubated smoothly with FOB through CILA at the first attempt, and one was intubated by FOB via CILA at the second attempt. Compared to CILA group, the time of FT-LMA insertion was significantly longer.

In registry study, 7 cases were intubated using CILA with FOB, 8 patients using FT-LMA with FOB and 6 cases using CTrach ILA. In CILA group, 5 patients with limited mouth opening < 15mm, 11cm was the least one among of these cases.The least mouth opening was 15mm in Fastrach and CTrach group. The success rate was no significant difference during the three groups, but compared with CILA group, the time of FT-LMA and CTrach insertion were significantly longer.

Part Two：Simulation training of emergency airway management  

Methods: A questionnaire is produced by making use of the mobile phone WeChat platform in order to investigate the knowledge, skill and confidence of Chinese anesthesiologists on performing cricothyrotomy. “cricothyrotomy training” vedio is made through searching a large number of literature and relevant materials, with the great help of the anatomists, three-dimensional animation and teaching video production specialists. Taking advantange of the unexpensive materials to design and make the economic and practical training model for training cricothyrotomy procedure. During emergency cricothyrotyomy simulation training, the information about the knowledge, skill and confidence of the trainees before training, after didactic instruction, and after simulation training will be gathered by finishing a questionnaire respectively. Two judges score the task-specific checklist and the global rating scale according to the operation videos of the trainees recorded after the didactic instruction and after simulation training.

 Results: 445 effective questionnaires showed that, nearly 60% of the anesthesiologists don’t clearly know the local anatomy of the criothyroid membrane; only less than 10% of the anesthesiologists master the skills of cricothyrotomy procedure; and more than 65% of the anesthesiologists have never received the skill training of cricothyrotomy. A 30-minute intstructional vedio on the performance of cricothyrotomy is elaborated which covers Difficult Airway Society 2015 guidelines for management of unanticipated difficult intubation in adults; the three-dimensional animation display of the cricothyroid membrane local anatomy, and the detailed explanation of the cricothyrotomy procedural skills as well as the method to make the simple model for cricothyrotomy training and the related knowledge that must be known to operate the emergency cricothyrotomy. The cricothytomy training model which is designed and produced has obtained a national practical new type patent. It has established and improved the appropriate teaching method and evaluation system of cricothyrotomy training through carrying out the simulation training.The results of this study demonstrated that the simulation training can significantly improve trianees’knowledge and confidence on performing cricothyrotomy compared with the results before training and after didactic instruction. Also, the task-specific checklist score and the global rating scale have significantly improved.

Conclusions:

It is safe and effective of FOB-guided intubation through CILA and FT-LMA in serious anticipated difficult tracheal intubation. However, in patients with serious scar contracture of face and neck and/or patients with huge expender in neck, the success rate of the CILA insertion and FOB-guided intubation via CILA is higher than that of FT-LMA.

All three types of ILA are safe and effective tools for predicted severe difficult airways, but CILA has obvious advantages for patients with at least one of the presences: mouth opening < 15mm; severe cervical scar contracture malformations; large skin soft -tissue expanders implanted in cervical area.

It is extremely necessary to carry out the procedural skill training of emergency cricothyrotomy for the anesthesiologists. Meanwhile, the vast majority of the anesthesiologists are eager to accept emergency airway management training.

The elaborated intstructional vedio and training model can meet the demand of the cricothyrotomy skill training.

The simulation training significantly improves knowledge, skill and self-confidence of trianees on performing cricothyrotomy.