Guy's & St Thomas' NHS Foundation Trust, London, UK.
King's College London, UK.
Anaesthesia. 2019 Feb;74(2):225-236. doi: 10.1111/anae.14471. Epub 2018 Nov 20.
Recent controversy regarding the ethics of conducting airway research in patients led to disagreements concerning the value and frequency of manikin-based investigation. However, no formal examination of the methodology of airway research has been undertaken. We, therefore, performed a systematic bibliometric review of airway management research to describe the conduct, quantify the subjects (patient vs. manikin vs. other), assess the reported outcomes and map global trends. We retrieved 1505 relevant studies published between 2006 and 2017, together recruiting 359,648 subjects, of which 341,233 were patients, the remaining being volunteers or subjects managing manikins, human cadavers, animals or bench models. There were 701 randomised controlled clinical trials (46.6%), 83 non-randomised experimental clinical trials (5.5%), 298 observational studies (19.8%) and 423 non-patient studies (28.1%). A total of 1082 studies (71.9%) were patient studies and 322 were manikin studies (21.4%). The total annual number of airway management studies increased over time, as did the annual number of patient studies, but there was no significant increase in the annual number of manikin studies over time. Of the patient studies, subject baseline characteristics were most likely to be ASA status 1-2 (n = 531, 49.1%), populations were most often elective surgical patients (n = 918, 84.8%) and the most common interventions studied were tracheal intubation (n = 820, 54.4%) or supraglottic airway device insertion (n = 257, 17.1%). There was a total of 77 different primary outcomes used in the included studies, the most commonly reported being success rate and procedure time. By understanding how and what has been previously studied these data can be used to form the basis for future priority setting exercises, core outcome set development, and could inform strategy on the future directions of airway management research.
最近,有关在患者身上进行气道研究的伦理问题引起了争议,这涉及到对基于模型的研究的价值和频率的不同看法。然而,目前还没有对气道研究方法进行正式的检查。因此,我们对气道管理研究进行了系统的文献计量学回顾,以描述其实施情况,量化研究对象(患者与模型与其他),评估报告的结果,并绘制全球趋势。我们检索了 2006 年至 2017 年间发表的 1505 项相关研究,共招募了 359648 名受试者,其中 341233 名是患者,其余为志愿者或管理模型、人体尸体、动物或台架模型的受试者。701 项为随机对照临床试验(46.6%),83 项为非随机实验性临床试验(5.5%),298 项为观察性研究(19.8%),423 项为非患者研究(28.1%)。总共 1082 项研究(71.9%)为患者研究,322 项为模型研究(21.4%)。气道管理研究的年总数随着时间的推移而增加,患者研究的年总数也在增加,但模型研究的年总数并没有随着时间的推移而显著增加。在患者研究中,研究对象的基线特征最有可能是 ASA 1-2 级(n=531,49.1%),研究人群最常为择期手术患者(n=918,84.8%),研究中最常见的干预措施是气管插管(n=820,54.4%)或声门上气道装置插入(n=257,17.1%)。纳入研究共使用了 77 种不同的主要结局,报告最频繁的是成功率和操作时间。通过了解以前的研究方法和内容,可以利用这些数据为未来的优先事项设定、核心结局集的开发提供依据,并为气道管理研究的未来方向提供策略。