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一种用于院前急性胸痛的决策支持工具的开发——一项观察性研究(BRIAN2)的研究方案

The development of a decision support tool in the prehospital setting for acute chest pain - a study protocol for an observational study (BRIAN2).

作者信息

Lökholm Elin, Magnusson Carl, Herlitz Johan, Ravn-Fischer Annica, Hammarsten Ola, Johansson Magnus, Hallin Kristoffer, Wibring Kristoffer

机构信息

Department of Prehospital Emergency Care, Sahlgrenska University Hospital, Gothenburg, Sweden.

Department of Molecular and Clinical Medicine, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.

出版信息

Scand J Trauma Resusc Emerg Med. 2025 Jan 6;33(1):4. doi: 10.1186/s13049-024-01314-x.

Abstract

INTRODUCTION

Chest pain is one of the most common reasons for contacting the emergency medical services (EMS). It is difficult for EMS personnel to distinguish between patients suffering from a high-risk condition in need of prompt hospital care and patients suitable for non-conveyance. A vast majority of patients with chest pain are therefore transported to the emergency department (ED) for further investigation even if hospital care is not necessary. Improved prehospital assessment and risk stratification, thus accurately and safely identifying patients suitable for non-conveyance, could prevent unnecessary transport to the ED. This would reduce ED crowding and overburdening sparse EMS resources. It would thus also probably reduce healthcare costs. Little is known about the prehospital use of the 5th generation, i.e. high-sensitivity troponin analyses. The aim of this project is to develop an EMS decision support tool using high-sensitivity troponin I for risk assessment of chest pain patients.

METHODS AND ANALYSIS

This is a prospective, multicentre, cohort study including adult unselected EMS patients with chest pain. Data is being collected from 20 May 2023 to 31 December 2025, aiming to include at least 2,000 patients. High-sensitivity troponin I is being analysed bedside using Siemens Healthineers Atellica VTLi. In addition to prehospital troponin I, data is being collected on patient medical history, onset, vital signs, symptoms, ECG and diagnosis at hospital discharge. Several statistical analyses (random forest, logistic regression, gradient boosting) will be conducted to identify the best model for identifying patients with low-risk conditions suitable for non-conveyance.

ETHICS AND DISSEMINATION

The study has been approved by the Swedish Ethical Review Authority (Dnr 2022-01066-01 and 2022-06846-02). Patients are being informed about the study both orally and in writing. The results of the study will be published in a peer-reviewed journal and will be presented at national and/or international conferences.

REGISTRATION DETAILS

The study is registered at ClinicalTrials.gov (NCT05767619).

摘要

引言

胸痛是呼叫紧急医疗服务(EMS)的最常见原因之一。紧急医疗服务人员很难区分需要及时住院治疗的高危患者和适合不转运的患者。因此,即使不需要住院治疗,绝大多数胸痛患者也会被送往急诊科(ED)进行进一步检查。改进院前评估和风险分层,从而准确、安全地识别适合不转运的患者,可以避免不必要地送往急诊科。这将减少急诊科的拥挤情况,减轻稀缺的紧急医疗服务资源的负担。因此,这也可能降低医疗成本。关于第五代即高敏肌钙蛋白分析在院前的应用,人们了解甚少。本项目的目的是开发一种使用高敏肌钙蛋白I的紧急医疗服务决策支持工具,用于胸痛患者的风险评估。

方法与分析

这是一项前瞻性、多中心队列研究,纳入未经过筛选的成年胸痛紧急医疗服务患者。数据收集时间为2023年5月20日至2025年12月31日,目标是纳入至少2000名患者。使用西门子医疗Atellica VTLi在床边分析高敏肌钙蛋白I。除了院前肌钙蛋白I,还收集患者病史、发病情况、生命体征、症状、心电图以及出院诊断等数据。将进行多项统计分析(随机森林、逻辑回归、梯度提升),以确定识别适合不转运的低风险患者的最佳模型。

伦理与传播

该研究已获得瑞典伦理审查局批准(编号2022 - 01066 - 01和2022 - 06846 - 02)。已通过口头和书面形式告知患者有关该研究的情况。研究结果将发表在同行评审期刊上,并将在国家和/或国际会议上展示。

注册详情

该研究已在ClinicalTrials.gov注册(NCT05767619)。

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