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在高风险医疗程序前指导经验不足的临床医生:随机临床试验

Coaching inexperienced clinicians before a high stakes medical procedure: randomized clinical trial.

作者信息

Flynn Stephen G, Park Raymond S, Jena Anupam B, Staffa Steven J, Kim Samuel Y, Clarke Julia D, Pham Ivy V, Lukovits Karina E, Huang Sheng Xiang, Sideridis Georgios D, Bernier Rachel S, Fiadjoe John E, Weinstock Peter H, Peyton James M, Stein Mary Lyn, Kovatsis Pete G

机构信息

Department of Anesthesia, Harvard Medical School, Boston, MA 02115, USA

Department of Anesthesiology, Critical Care, and Pain Medicine, Boston Children's Hospital, Boston, MA, USA.

出版信息

BMJ. 2024 Dec 16;387:e080924. doi: 10.1136/bmj-2024-080924.

Abstract

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.

摘要

目的

评估在经验不足的临床医生进行高风险操作之前提供的培训是否能提高操作护理质量,以测量实习生进行婴儿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一家单中心四级儿童医院。

参与者

采用了非交叉、前瞻性、平行组、非盲法试验设计。志愿者实习生包括来自10个地区培训项目的儿科麻醉住院医师、实习医生和注册护士麻醉专业学生,他们正处于儿科麻醉轮转期间。实习生按培训角色进行整群随机分组。纳入标准为对年龄≤12个月、美国麻醉医师协会身体状况分级为I-III级的婴儿进行插管的实习生。排除标准为对患有紫绀型先天性心脏病、已知或疑似困难或危急气道、在室内空气中基线氧饱和度<96%、已存在气管内或气管造口管、急诊病例或新冠病毒感染的婴儿进行插管的实习生。

干预措施

实习生治疗组在婴儿插管前一小时内接受在模拟人上进行的术前即时专家插管指导;对照组进行标准操作(由主治儿科麻醉医生提供非结构化的术中指导)。

主要结局指标

主要结局为术中婴儿插管的首次尝试成功率。改良意向性分析使用广义估计方程来考虑每个实习生参与者的多次插管情况。次要结局为并发症发生率、插管的认知负荷和能力指标。

结果

对250名实习生进行了资格评估;78人被排除,172人被随机分组,随后对153人进行了分析。在2020年8月1日至2022年4月30日期间,153名实习生(83名对照组,70名治疗组)进行了515次插管(283次对照组,232次治疗组)。在改良意向性分析中,实习生治疗组的首次尝试成功率为91.4%(212/232),对照组为81.6%(231/283)(优势比2.42(95%置信区间1.45至4.04),P = 0.001)。次要结局有利于干预组,在降低认知负荷和提高能力方面显示出显著性。干预组的并发症低于对照组,但差异不显著。

结论

经验不足的临床医生进行即时培训可提高婴儿插管的首次尝试成功率。将即时方法纳入气道管理可提高患者安全性,这些发现可能有助于更广泛地改善高风险操作。有必要在其他环境中进行随机评估。

试验注册

ClinicalTrials.gov NCT04472195。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8c9c/11648086/a80d5183efcf/flys080924.f1.jpg

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