Department of Anesthesia, St. Paul's Hospital/Providence Health Care, 1081 Burrard St, Vancouver, BC, V6Z 1Y6, Canada.
Department of Anesthesiology, Pharmacology and Therapeutics, University of British Columbia, Vancouver, BC, Canada.
Can J Anaesth. 2021 Sep;68(9):1358-1367. doi: 10.1007/s12630-021-02024-z. Epub 2021 May 10.
Novel devices such as the barrier enclosure were developed in hopes of improving provider safety by limiting SARS-CoV-2 transmission during tracheal intubation. Nevertheless, concerns arose regarding a lack of rigorous efficacy and safety data for these devices. We conducted a randomized controlled trial to evaluate the impact of the barrier enclosure on time to tracheal intubation.
After Research Ethics Board approval, elective surgical patients with normal airway predictors were randomly allocated 1:1 to tracheal intubation with or without a barrier enclosure. The primary outcome was time to tracheal intubation. Secondary outcomes included first-pass success rate, total time of airway manipulation, anesthesiologists' perception of intubation difficulty, likelihood of use in SARS-CoV-2-positive patients, and patients' perception of comfort and acceptability.
There were 48 participants in the barrier enclosure group and 46 participants in the control group. The mean (standard deviation [SD]) time to tracheal intubation was 62 (29) sec with barrier closure and 53 (27) sec without barrier enclosure (mean difference, 9 sec; 95% confidence interval, - 3 to 20; P = 0.14). Anesthesiologists rated the difficulty of intubation higher with barrier enclosure (mean [SD] visual analogue scale score, 27 [26] mm vs 9 [17] mm; P < 0.001). There were no significant differences in other secondary outcomes.
In healthy surgical patients with normal airway predictors, the use of a barrier enclosure during tracheal intubation did not significantly prolong time to intubation or decrease first-pass intubation success. Nevertheless, there was an increase in difficulty of intubation perceived by the anesthesiologists with use of a barrier enclosure.
www.clinicaltrials.gov (NCT04366141); registered 28 April 2020.
为了在进行气管插管时限制 SARS-CoV-2 的传播，从而提高医护人员的安全性，新型设备（如屏障罩）应运而生。然而，人们对这些设备缺乏严格的疗效和安全性数据表示担忧。我们开展了一项随机对照试验，以评估屏障罩对气管插管时间的影响。
在获得伦理委员会批准后，我们将具有正常气道预测指标的择期手术患者随机分为气管插管加用或不加用屏障罩组，每组各 48 例和 46 例。主要结局是气管插管时间。次要结局包括首次插管成功率、气道操作总时间、麻醉医师对插管难度的感知、在 SARS-CoV-2 阳性患者中使用的可能性，以及患者对舒适度和可接受性的感知。
屏障罩组和对照组的气管插管中位（标准差 [SD]）时间分别为 62（29）s 和 53（27）s（平均差值 9 s；95%置信区间，-3 至 20；P = 0.14）。麻醉医师认为使用屏障罩时插管难度更高（平均 [SD] 视觉模拟量表评分分别为 27[26]mm 和 9[17]mm；P < 0.001）。其他次要结局无显著差异。
在具有正常气道预测指标的健康手术患者中，气管插管时使用屏障罩并不会显著延长插管时间或降低首次插管成功率。然而，使用屏障罩会增加麻醉医师感知到的插管难度。
www.clinicaltrials.gov（NCT04366141）；注册于 2020 年 4 月 28 日。
