Objective To assess whether training provided to an inexperienced clinician just before performing a high stakes procedure can improve procedural care quality, measuring the first attempt success rate of trainees performing infant orotracheal intubation. Design Randomized clinical trial. Setting Single center, quaternary children’s hospital in Boston, MA, USA. Participants A non-crossover, prospective, parallel group, non-blinded, trial design was used. Volunteer trainees comprised pediatric anesthesia fellows, residents, and student registered nurse anesthetists from 10 regional training programs during their pediatric anesthesiology rotation. Trainees were block randomized by training roles. Inclusion criteria were trainees intubating infants aged ≤12 months with an American Society of Anesthesiology physical status classification of I-III. Exclusion criteria were trainees intubating infants with cyanotic congenital heart disease, known or suspected difficult or critical airways, pre-existing abnormal baseline oxygen saturation <96% on room air, endotracheal or tracheostomy tubes in situ, emergency cases, or covid-19 infection. Interventions Trainee treatment group received preoperative just-in-time expert intubation coaching on a manikin within one hour of infant intubation; control group carried out standard practice (receiving unstructured intraoperative instruction by attending pediatric anesthesiologists). Main outcome measures Primary outcome was the first attempt success rate of intraoperative infant intubation. Modified intention-to-treat analysis used generalized estimating equations to account for multiple intubations per trainee participant. Secondary outcomes were complication rates, cognitive load of intubation, and competency metrics. Results 250 trainees were assessed for eligibility; 78 were excluded, 172 were randomized, and 153 were subsequently analyzed. Between 1 August 2020 and 30 April 2022, 153 trainees (83 control, 70 treatment) did 515 intubations (283 control, 232 treatment). In modified intention-to-treat analysis, first attempt success was 91.4% (212/232) in the trainee treatment group and 81.6% (231/283) in the control group (odds ratio 2.42 (95% confidence interval 1.45 to 4.04), P=0.001). Secondary outcomes favored the intervention, showing significance for decreased cognitive load and improved competency. Complications were lower for the intervention than for the control group but the difference was not significant. Conclusions Just-in-time training among inexperienced clinicians led to increased first attempt success of infant intubation. Integration of a just-in-time approach into airway management could improve patient safety, and these findings could help to improve high stakes procedures more broadly. Randomized evaluation in other settings is warranted. Trial registration ClinicalTrials.gov [NCT04472195][1]. Research data will be made available after publication on reasonable request after review by SGF and other study team members. A data use agreement will be required before the release of data and the institutional review board’s approval as appropriate. [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT04472195&atom=%2Fbmj%2F387%2Fbmj-2024-080924.atom

中文翻译：

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在高风险医疗程序之前指导没有经验的临床医生：随机临床试验


目的 评估在进行高风险手术之前向没有经验的临床医生提供的培训是否可以提高手术护理质量，测量受训者进行婴儿经口气管插管的首次尝试成功率。设计 随机临床试验。地点 美国马萨诸塞州波士顿的单中心四级儿童医院。参与者 使用非交叉、前瞻性、平行组、非盲法、试验设计。志愿者实习生包括儿科麻醉研究员、住院医师和学生注册护士麻醉师，他们来自儿科麻醉学轮换期间的 10 个区域培训计划。受训者按训练角色进行块随机分配。纳入标准是受训者对 ≤12 个月大的婴儿进行插管，美国麻醉学会身体状况分类为 I-III。排除标准是受训者为患有紫绀型先天性心脏病、已知或疑似困难或危急气道、室内空气中预先存在的异常基线氧饱和度 <96%、气管内或气管切开插管原位、紧急情况或 covid-19 感染。干预措施 实习生治疗组在婴儿插管后 1 小时内接受人体模型术前及时专家插管指导;对照组执行标准做法 （接受主治儿科麻醉师的非结构化术中指导）。主要结局指标 主要结局是婴儿术中插管的首次尝试成功率。改良的意向治疗分析使用广义估计方程来解释每个受训参与者的多次插管。次要结局是并发症发生率、插管的认知负荷和能力指标。 结果 250 名学员接受了资格评估;排除 78 例，随机分配 172 例，随后分析 153 例。在 2020 年 8 月 1 日至 2022 年 4 月 30 日期间，153 名受训者（83 名对照，70 名治疗）进行了 515 次插管（283 名对照，232 名治疗）。在改良意向治疗分析中，受训治疗组的首次尝试成功率为 91.4% （212/232），对照组为 81.6% （231/283） （比值比 2.42 （95% 置信区间 1.45 至 4.04），P = 0.001）。次要结局有利于干预，显示出降低认知负荷和提高能力的意义。干预组的并发症发生率低于对照组，但差异不显著。结论 对缺乏经验的临床医生进行及时培训，提高了婴儿插管的首次尝试成功率。将及时方法整合到气道管理中可以提高患者安全，这些发现可能有助于更广泛地改进高风险程序。在其他情况下进行随机评估是必要的。试验注册 ClinicalTrials.gov [NCT04472195][1]。研究数据将在 SGF 和其他研究团队成员审查后，根据合理要求提供。在发布数据并酌情获得机构审查委员会的批准之前，需要签订数据使用协议。[1]： /lookup/external-ref？link_type=CLINTRIALGOV&access_num=NCT04472195&atom=%2Fbmj%2F387%2Fbmj-2024-080924.原子