Sainsbury Jennifer E, Telgarsky Branislav, Parotto Matteo, Niazi Ahtsham, Wong David T, Cooper Richard M
Department of Anesthesia, Toronto General Hospital, University Health Network, University of Toronto, Toronto, ON, Canada.
Department of Anesthesia, Toronto Western Hospital, University Health Network, University of Toronto, Toronto, ON, Canada.
Can J Anaesth. 2017 Mar;64(3):252-259. doi: 10.1007/s12630-016-0792-x. Epub 2016 Dec 27.
Skill acquisition in direct laryngoscopy (DL) and tracheal intubation is complex. This pilot study aims to assess feasibility and determine sample size for a subsequent trial comparing DL instruction using a Macintosh-style video laryngoscope (MacVL), with and without video recordings, with conventional DL instruction.
Medical students with no prior laryngoscopy experience were recruited during their two-week anesthesia rotation. During the first (TRAINING) week, students were randomized into three groups: Control (Macintosh direct laryngoscope), VL-1 (MacVL with real-time feedback), and VL-2 (MacVL with real-time feedback plus video recordings of laryngoscopies). During the second (TESTING) week, all students were tested using a Macintosh direct laryngoscope. Feasibility objectives were recruitment and attrition rates, ability to time and video record intubations, and the availability of a MacVL. The primary clinical outcome during the TESTING week was total time to intubate, and secondary outcomes included intubation success rate, intubating opportunities, complications, and confidence scores.
Sixty-eight of 87 (78%) consecutive medical students approached to participate in the study were recruited over 18 months. Eight (12%) students withdrew from the study, and data are available on the remaining 60 participants. The times to intubate were recorded for 92% of the TESTING intubations, but only 71% of the TRAINING intubations in the VL-2 group were video recorded. The MacVLs were available in 100% of cases. We estimate that 190 participants would be required for a study restricted to a comparison of DL vs video laryngoscopy with real-time feedback.
This pilot study establishes feasibility and provides a sample size estimate for a future RCT. Required modifications to the study protocol include wider hospital involvement and consideration regarding standardization of airway education, teaching, feedback, and patient characteristics.
直接喉镜检查（DL）和气管插管的技能习得过程较为复杂。这项初步研究旨在评估可行性，并为后续一项比较使用麦金托什式视频喉镜（MacVL）进行DL教学（有无视频记录）与传统DL教学的试验确定样本量。
在为期两周的麻醉轮转期间招募此前无喉镜检查经验的医学生。在第一周（培训周），学生被随机分为三组：对照组（麦金托什直接喉镜）、VL - 1组（带实时反馈的MacVL）和VL - 2组（带实时反馈及喉镜检查视频记录的MacVL）。在第二周（测试周），所有学生使用麦金托什直接喉镜进行测试。可行性目标包括招募率和损耗率、对插管进行计时和视频记录的能力以及MacVL的可用性。测试周的主要临床结局是插管总时间，次要结局包括插管成功率、插管机会、并发症和信心评分。
在18个月内，连续邀请参与研究的87名医学生中有68名（78%）被招募。8名（12%）学生退出研究，其余60名参与者的数据可用。92%的测试插管记录了插管时间，但VL - 2组培训插管中只有71%进行了视频记录。MacVL在所有病例中均可用。我们估计，一项仅限于比较DL与带实时反馈的视频喉镜检查的研究需要190名参与者。
这项初步研究确立了可行性，并为未来的随机对照试验提供了样本量估计。研究方案所需的修改包括扩大医院参与度以及考虑气道教育、教学、反馈和患者特征的标准化。
