Department of Anesthesiology and Critical Care Medicine, University of Pennsylvania, Perelman School of Medicine, The Children's Hospital of Philadelphia, Philadelphia, PA, USA.
Department of Anesthesiology, Critical Care and Pain Medicine, Harvard Medical School, Boston Children's Hospital Boston, MA, USA.
Lancet. 2020 Dec 12;396(10266):1905-1913. doi: 10.1016/S0140-6736(20)32532-0.
Orotracheal intubation of infants using direct laryngoscopy can be challenging. We aimed to investigate whether video laryngoscopy with a standard blade done by anaesthesia clinicians improves the first-attempt success rate of orotracheal intubation and reduces the risk of complications when compared with direct laryngoscopy. We hypothesised that the first-attempt success rate would be higher with video laryngoscopy than with direct laryngoscopy.
In this multicentre, parallel group, randomised controlled trial, we recruited infants without difficult airways abnormalities requiring orotracheal intubation in operating theatres at four quaternary children's hospitals in the USA and one in Australia. We randomly assigned patients (1:1) to video laryngoscopy or direct laryngoscopy using random permuted blocks of size 2, 4, and 6, and stratified by site and clinician role. Guardians were masked to group assignment. The primary outcome was the proportion of infants with a successful first attempt at orotracheal intubation. Analysis (modified intention-to-treat [mITT] and per-protocol) used a generalised estimating equation model to account for clustering of patients treated by the same clinician and institution, and adjusted for gestational age, American Society of Anesthesiologists physical status, weight, clinician role, and institution. The trial is registered at ClinicalTrials.gov, NCT03396432.
Between June 4, 2018, and Aug 19, 2019, 564 infants were randomly assigned: 282 (50%) to video laryngoscopy and 282 (50%) to direct laryngoscopy. The mean age of infants was 5·5 months (SD 3·3). 274 infants in the video laryngoscopy group and 278 infants in the direct laryngoscopy group were included in the mITT analysis. In the video laryngoscopy group, 254 (93%) infants were successfully intubated on the first attempt compared with 244 (88%) in the direct laryngoscopy group (adjusted absolute risk difference 5·5% [95% CI 0·7 to 10·3]; p=0·024). Severe complications occurred in four (2%) infants in the video laryngoscopy group compared with 15 (5%) in the direct laryngoscopy group (-3·7% [-6·5 to -0·9]; p=0·0087). Fewer oesophageal intubations occurred in the video laryngoscopy group (n=1 [<1%]) compared with in the direct laryngoscopy group (n=7 [3%]; -2·3 [-4·3 to -0·3]; p=0·028).
Among anaesthetised infants, using video laryngoscopy with a standard blade improves the first-attempt success rate and reduces complications.
Anaesthesia Patient Safety Foundation, Society for Airway Management, and Karl Storz Endoscopy.
使用直接喉镜对婴儿进行经口气管插管可能具有挑战性。我们旨在研究在麻醉临床医生使用标准叶片的视频喉镜下，与直接喉镜相比，是否可以提高经口气管插管的首次尝试成功率并降低并发症的风险。我们假设视频喉镜的首次尝试成功率会高于直接喉镜。
在这项多中心、平行组、随机对照试验中，我们招募了在美国的四家四级儿童医院和澳大利亚的一家医院的手术室中需要经口气管插管但无气道异常的婴儿。我们使用大小为 2、4 和 6 的随机排列块，以 1:1 的比例随机分配患者（视频喉镜或直接喉镜），并按地点和临床医生角色分层。监护人对分组情况不知情。主要结局是经口气管插管首次尝试成功的婴儿比例。（修改后的意向治疗[mITT]和方案）使用广义估计方程模型来解释同一临床医生和机构治疗的患者的聚类，并根据胎龄、美国麻醉医师协会身体状况、体重、临床医生角色和机构进行调整。该试验在 ClinicalTrials.gov 上注册，NCT03396432。
2018 年 6 月 4 日至 2019 年 8 月 19 日期间，共有 564 名婴儿被随机分配：282 名（50%）接受视频喉镜检查，282 名（50%）接受直接喉镜检查。婴儿的平均年龄为 5.5 个月（标准差 3.3）。视频喉镜组有 274 名婴儿和直接喉镜组有 278 名婴儿纳入 mITT 分析。在视频喉镜组中，254 名（93%）婴儿首次尝试插管成功，而直接喉镜组有 244 名（88%）婴儿（调整后的绝对风险差异 5.5%[95%CI 0.7 至 10.3]；p=0.024）。视频喉镜组有 4 名（2%）婴儿发生严重并发症，而直接喉镜组有 15 名（5%）婴儿（-3.7%[-6.5 至 -0.9]；p=0.0087）。视频喉镜组的食管插管较少（n=1[＜1%]），而直接喉镜组（n=7[3%]）（-2.3[-4.3 至 -0.3]；p=0.028）。
在麻醉婴儿中，使用标准叶片的视频喉镜可提高首次尝试成功率并降低并发症风险。
麻醉患者安全基金会、气道管理学会和卡尔·史托斯内窥镜公司。
