Geneva Children's Hospital, Department of Paediatric Emergency Medicine, Geneva University Hospitals, Geneva, Switzerland.
Division of Medical Information Sciences, Department of Radiology and Medical Informatics, Geneva University Hospitals, Geneva, Switzerland.
Lancet Child Adolesc Health. 2019 May;3(5):303-311. doi: 10.1016/S2352-4642(19)30003-3. Epub 2019 Feb 21.
Vasoactive drug preparation for continuous infusion in children is both complex and time consuming and places the paediatric population at higher risk than adults for medication errors. We developed a mobile device application (app) as a step-by-step guide for the preparation to delivery of drugs requiring continuous infusion. The app has been previously tested during simulation-based resuscitations in a previous single-centre trial. In this trial, our aim was to assess this app in various hospital settings.
We did a prospective, multicentre, randomised, controlled, crossover trial to compare this app with an internationally used drug-infusion-rates table for the preparation of continuous drug infusion during standardised, simulation-based, paediatric post-cardiac arrest scenarios using a high-fidelity manikin. The scenarios were split into two study periods to assess the two preparation methods consecutively, separated by a washout distraction manoeuvre. Nurses in six paediatric emergency centres in Switzerland were randomly assigned (1:1) to start the scenario with either the app or the infusion-rates table and then complete the scenario using the other preparation method. The primary endpoint was the proportion of participants committing a medication error, which was defined as a deviation from the correct weight dose of more than 10%, miscalculation of the infusion rate, misprogramming of the infusion pump, or the inability to calculate drug dosage without calculation and guidance help from the study team. The medication error proportions observed with both preparation methods were compared by pooling both study periods, with paired data analysed using the unconditional exact McNemar test for dependent groups with a two-sided α level of 0·05. We did sensitivity analyses to investigate the carryover effect. This trial is registered with ClinicalTrials.gov, number NCT03021122.
From March 1 to Dec 31, 2017, we randomly assigned 128 nurses to start the scenario using the app (n=64) or the infusion-rates table (n=64). Among the 128 drug preparations associated with each of the two methods, 96 (75%, 95% CI 67-82) delivered using the infusion-rates table were associated with medication errors compared with nine (7%, 3-13) delivered using the mobile app. Medication errors were reduced by 68% (95% CI 59-76%; p<0·0001) with the app compared with the table, as was the mean time to drug preparation (difference 148·2 s [95% CI 124·2-172·1], a 45% reduction; p<0·0001) and mean time to drug delivery (168·5 s [146·1-190·8], a 40% reduction; p<0·0001). Hospital size and nurses' experience did not modify the intervention effect. We detected no carryover effect.
Critically ill children are particularly vulnerable to medication errors. A mobile app designed to help paediatric drug preparation during resuscitation with the aim to significantly reduce the occurrence of medication errors, drug preparation time, and delivery time could have the potential to change paediatric clinical practice in the area of emergency medicine.
Swiss National Science Foundation.
儿童连续输注血管活性药物的准备工作既复杂又耗时，使儿科人群比成人更容易发生用药错误。我们开发了一种移动设备应用程序（app），作为药物连续输注准备到交付的分步指南。该应用程序已在之前的一项单中心试验中的基于模拟的复苏中进行了测试。在这项试验中，我们的目的是在各种医院环境中评估该应用程序。
我们进行了一项前瞻性、多中心、随机、对照、交叉试验，以比较该应用程序与国际上使用的药物输注速率表，用于在使用高保真人体模型的标准化、基于模拟的儿科心脏骤停后场景中准备连续药物输注。该场景分为两个研究期，以连续评估两种准备方法，中间用清洗分散操作分开。瑞士六家儿科急救中心的护士被随机（1:1）分配，使用 app 或输注速率表开始场景，然后使用另一种准备方法完成场景。主要终点是参与者发生用药错误的比例，定义为剂量超过正确体重的 10%、输注率计算错误、输注泵编程错误或无法计算药物剂量而无需研究团队的计算和指导帮助。通过对两个研究期的数据进行合并，使用无条件精确 McNemar 检验对依赖组进行双侧检验，检验水平为 0.05，比较两种准备方法观察到的用药错误比例。我们进行了敏感性分析以研究残留效应。该试验在 ClinicalTrials.gov 注册，编号为 NCT03021122。
从 2017 年 3 月 1 日至 12 月 31 日，我们随机分配 128 名护士使用 app（n=64）或输注速率表（n=64）开始场景。与两种方法中的每一种相关的 128 次药物准备中，与使用输注速率表相关的 96 次（75%，95%CI 67-82%）与用药错误相关，而使用移动应用程序相关的只有 9 次（7%，3-13%）。与使用输注速率表相比，使用 app 可将用药错误减少 68%（95%CI 59-76%；p<0·0001），准备药物的平均时间也减少了 148.2s（95%CI 124.2-172.1s，减少了 45%；p<0·0001），药物输送的平均时间也减少了 168.5s（146.1-190.8s，减少了 40%；p<0·0001）。医院规模和护士的经验并没有改变干预效果。我们没有检测到残留效应。
危重症儿童特别容易发生用药错误。旨在显著减少用药错误、药物准备时间和输送时间的用于儿科复苏期间药物准备的移动应用程序，有可能改变急救医学领域的儿科临床实践。
瑞士国家科学基金会。
