Children's Hospital, Department of Pediatric Emergency Medicine, Geneva University Hospitals, 47 Avenue de la Roseraie, 1211, Geneva 14, Switzerland.
A.C.E. Geneva Ambulances SA, 2 Route de Jussy, 1225, Geneva, Switzerland.
Trials. 2019 Nov 20;20(1):634. doi: 10.1186/s13063-019-3726-4.
Emergency drug preparation and administration in children is both complex and time-consuming and places this population at a higher risk than adults for medication errors. Moreover, survival and a favorable neurological outcome from cardiopulmonary resuscitation are inversely correlated to drug preparation time. We developed a mobile device application (the pediatric Accurate Medication IN Emergency Situations (PedAMINES) app) as a step-by-step guide for the preparation to delivery of drugs requiring intravenous injection. In a previous multicenter randomized trial, we reported the ability of this app to significantly reduce in-hospital continuous infusion medication error rates and drug preparation time compared to conventional preparation methods during simulation-based pediatric resuscitations. This trial aims to evaluate the effectiveness of this app during pediatric out-of-hospital cardiopulmonary resuscitation.
METHODS/DESIGN: We will conduct a multicenter, prospective, randomized controlled trial to compare the PedAMINES app with conventional calculation methods for the preparation of direct intravenously administered emergency medications during standardized, simulation-based, pediatric out-of-hospital cardiac arrest scenarios using a high-fidelity manikin. One hundred and twenty paramedics will be randomized (1:1) in several emergency medical services located in different regions of Switzerland. Each paramedic will be asked to prepare, sequentially, four intravenously administered emergency medications using either the app or conventional methods. The primary endpoint is the medication error rates. Enrollment will start in mid-2019 and data analysis in late 2019. We anticipate that the intervention will be completed in early 2020 and study results will be submitted in late 2020 for publication (expected in early 2021).
This clinical trial will assess the impact of an evidence-based mobile device app to reduce the rate of medication errors, time to drug preparation and time to drug delivery during prehospital pediatric resuscitation. As research in this area is scarce, the results generated from this study will be of great importance and may be sufficient to change and improve prehospital pediatric emergency care practice.
ClinicalTrials.gov, ID: NCT03921346. Registered on 18 April 2019.
儿童的紧急药物准备和给药既复杂又耗时，使儿童比成人更容易发生用药错误。此外，心肺复苏的生存和良好的神经转归与药物准备时间呈反比。我们开发了一个移动设备应用程序（儿科准确药物 IN 紧急情况（PedAMINES）应用程序），作为静脉注射药物准备到给药的分步指南。在之前的多中心随机试验中，我们报告了与传统准备方法相比，该应用程序在模拟儿科复苏中显著降低了院内连续输注药物错误率和药物准备时间。本试验旨在评估该应用程序在儿科院外心肺复苏中的有效性。
方法/设计：我们将进行一项多中心、前瞻性、随机对照试验，在使用高保真模拟人进行标准化、模拟儿科院外心脏骤停场景中，比较 PedAMINES 应用程序与传统计算方法在直接静脉给予急救药物时的准备情况。将 120 名护理人员随机分为（1:1），分布在瑞士不同地区的几个紧急医疗服务中心。要求每位护理人员使用应用程序或传统方法依次准备四种静脉内给予的急救药物。主要终点是药物错误率。招募将于 2019 年年中开始，2019 年年末进行数据分析。我们预计干预将于 2020 年初完成，并于 2020 年年末提交研究结果进行发表（预计 2021 年初）。
本临床试验将评估基于证据的移动设备应用程序对降低院前儿科复苏中药物错误率、药物准备时间和药物输送时间的影响。由于该领域的研究较少，本研究产生的结果将非常重要，可能足以改变和改进院前儿科急救护理实践。
ClinicalTrials.gov，编号：NCT03921346。于 2019 年 4 月 18 日注册。
