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早期床边重点超声心动图作为院外心脏骤停患者无自主循环恢复预测因素的前瞻性、多中心观察研究方案。

Early point-of-care focused echocardiographic asystole as a predictive factor for absence of return of spontaneous circulatory in out-of-hospital cardiac arrests: a study protocol for a prospective, multicentre observational study.

机构信息

Emergency Medicine, Université de Nantes Faculte de Médecine, Nantes, France.

Emergency Department, Centre Hospitalier Universitaire de Nantes, Nantes, France.

出版信息

BMJ Open. 2019 Aug 30;9(8):e027448. doi: 10.1136/bmjopen-2018-027448.

Abstract

INTRODUCTION

Management of out-of-hospital cardiac arrests (OHCAs) in France is performed by a particular prehospital system based on medicalisation of mobile intensive care units composed of an emergency physician and a nurse with all the required devices for advanced care. It follows the European recommendations which advocate for the use of early point-of-care focused echocardiography (EPOCE) in the prehospital setting. An ability of EPOCE may be to predict the absence of return of spontaneous circulation (ROSC) in cases of absence of cardiac motion. We thus intended to investigate this predictive value with a prospective multicentre study. This paper describes the study protocol, while the first patients were recruited in December 2018.

METHODS

ACE is a prospective multicentre (n=8) prognostic study. Briefly, as soon as OHCA is diagnosed and advanced life support (ALS) is initiated, EPOCE will be performed during the automated external defibrillator' analysis period. The physician will assess detectable motion within the heart and reversible causes of OHCA. However, as the prognostic value of absence of cardiac motion is not currently validated, the results of EPOCE will not be used to withdraw ALS, and the decision to withdraw life support will be done following the European Resuscitation Council recommendations during our study.

ANALYSIS

The primary endpoint is the positive predictive value of absence of cardiac motion for the absence of final ROSC. The secondary endpoints are predictive characteristics of EPOCE asystole on morbimortality 30 days after OHCA, description of reversible cause and analysis of the EPOCE technique.

ETHICS AND DISSEMINATION

ACE was approved by an ethical committee (2018-AO1491-54). While ACE is adapted to the French prehospital system, its results will be translatable to other organisations if inter-rater variability is not found.

TRIAL REGISTRATION NUMBER

NCT03494153.

摘要

简介

法国的院外心脏骤停(OHCA)管理由一个特殊的院前系统执行,该系统基于配备所有高级护理所需设备的移动重症监护单元的医疗化。它遵循欧洲的建议,即在院前环境中提倡使用早期床边重点超声心动图(EPOCE)。EPOCE 的一个能力可能是预测在没有心脏运动的情况下,自主循环恢复(ROSC)的缺失。因此,我们旨在通过一项前瞻性多中心研究来调查这种预测价值。本文描述了研究方案,而第一批患者于 2018 年 12 月招募。

方法

ACE 是一项前瞻性多中心(n=8)预后研究。简而言之,一旦诊断出 OHCA 并开始高级生命支持(ALS),EPOCE 将在自动体外除颤器分析期间进行。医生将评估心脏内可检测的运动和 OHCA 的可逆原因。然而,由于目前尚未验证心脏运动缺失的预后价值,因此 EPOCE 的结果不会用于停止 ALS,并且在我们的研究中,将根据欧洲复苏委员会的建议来决定是否停止生命支持。

分析

主要终点是心脏运动缺失对最终 ROSC 缺失的阳性预测值。次要终点是 EPOCE 对 OHCA 后 30 天死亡率和发病率的停搏预测特征、可逆原因的描述以及 EPOCE 技术的分析。

伦理和传播

ACE 已获得伦理委员会的批准(2018-AO1491-54)。虽然 ACE 适用于法国的院前系统,但如果没有发现评分者间的变异性,其结果也可以转化为其他组织。

试验注册号

NCT03494153。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2ac1/6719758/75990ec945b3/bmjopen-2018-027448f01.jpg

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