Le Guen Morgan, Coppere Zoé, Dufour Guillaume, Ouattara Jonathan, Trichereau Julie, Fischler Marc
Department of Anesthesiology, Hopital Foch, Suresnes, Île-de-France, France.
Department of Anaesthesiology, Fondation Ophtalmologique Adolphe de Rothschild, Paris, Île-de-France, France.
BMJ Open. 2020 Jul 8;10(7):e036570. doi: 10.1136/bmjopen-2019-036570.
Tracheal intubation remains an everyday challenge for anaesthesiologists, even in patients without suspected difficult airways. The ideal positioning of the patient's head (flat, raised a few centimetres on a cushion in the sniffing position (SP), or raised to achieve horizontal alignment between the external acoustic meatus and the sternal angle) and the use of videolaryngoscopy remain controversial. This trial aims to compare the efficacy for orotracheal intubation of the SP or the head-elevated laryngoscopy position (HELP), which has been shown to improve laryngeal visualization and the intubation condition particularly in obese patients, in combination with a McGrath Mac videolaryngoscope whose video screen is either on or off (Video or NoVideo).
The HELP-VDL factorial trial is a prospective, randomised, parallel, multicentre, open study of 240 adult patients undergoing tracheal intubation under general anaesthesia. Patients will be allocated into four groups: SP-NoVideo, HELP-NoVideo, SP-Video and HELP-Video. The primary outcome is the proportion of orotracheal intubations that requires the assistance of a nurse anaesthetist. The secondary outcomes include the intubation duration, the first intubation success rate, the quality of visualisation of the glottis, the glottis visualisation score, adjunctive manoeuvres and alternative techniques used, the occurrence of oesophageal intubation, failure of tracheal intubation, the incidence of arterial oxygen desaturation, the perception of a difficult intubation, the score on the Intubation Difficulty Scale, cooperation among the members of the anaesthesia team, the evolution of vital signs and the frequency and severity of intubation complications. Data will be analysed on the intention-to-treat principle and a per-protocol basis.
Ethics approval was obtained from the Ethical Committee Ile de France V (Paris, France). Participant recruitment began on 3 July 2019. The results will be submitted for publication in peer-reviewed journals.NCT03987009; Pre-results.
气管插管对麻醉医生来说仍是一项日常挑战，即使是在没有疑似困难气道的患者中。患者头部的理想位置（平卧位、在嗅物位（SP）垫上抬高几厘米或抬高以实现外耳道与胸骨角水平对齐）以及视频喉镜的使用仍存在争议。本试验旨在比较SP或头高位喉镜检查位（HELP）在经口气管插管中的效果，HELP已被证明可改善喉镜视野和插管条件，尤其是在肥胖患者中，同时结合McGrath Mac视频喉镜，其视频屏幕开启或关闭（视频或无视频）。
HELP - VDL析因试验是一项前瞻性、随机、平行、多中心、开放性研究，纳入240例接受全身麻醉下气管插管的成年患者。患者将被分为四组：SP - 无视频、HELP - 无视频、SP - 视频和HELP - 视频。主要结局是需要麻醉护士协助的经口气管插管比例。次要结局包括插管持续时间、首次插管成功率、声门可视化质量、声门可视化评分、使用的辅助操作和替代技术、食管插管的发生情况、气管插管失败、动脉血氧饱和度下降的发生率、对困难插管的感知、插管难度量表评分、麻醉团队成员之间的协作、生命体征的变化以及插管并发症的频率和严重程度。数据将按照意向性分析原则和符合方案集进行分析。
获得了法国法兰西岛V伦理委员会（法国巴黎）的伦理批准。2019年7月3日开始招募参与者。结果将提交至同行评审期刊发表。NCT03987009；预结果。
