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  • 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

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Emergency medicine
Protocol
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
  1. François Javaudin1,2,
  2. Philippe Pes2,
  3. Emmanuel Montassier1,2,
  4. Arnaud Legrand3,
  5. Aline Ordureau3,
  6. Christelle Volteau3,
  7. Idriss Arnaudet2,
  8. Philippe Le Conte1,2
  1. 1Emergency Medicine, Université de Nantes Faculte de Médecine, Nantes, France
  2. 2Emergency Department, Centre Hospitalier Universitaire de Nantes, Nantes, France
  3. 3Centre Hospitalier Universitaire de Nantes, Nantes, France
  1. Correspondence to Professor Philippe Le Conte; philippe.leconte{at}chu-nantes.fr

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.

  • cardiac arrest
  • prognosis
  • cardiac ultrasound

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi.org/10.1136/bmjopen-2018-027448

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    Footnotes

    • Contributors FJ, PP, IA and PLC conceived and wrote the protocol. AL and AO brought methodological and administrative help. CV was in charge of the statistical aspect. EM reviewed the whole process.

    • Funding ACE is supported by a €193 000 grant from the French Ministry of Health (PHRC-IR 2017) (grant number API17/N/035). ACE is currently supported by the French Society of Emergency Medicine (Société Française de Médecine d’Urgence) and by Winfocus France without funding. There is ongoing discussions with Philips and SonoSite for the loan of echographic devices to increase the number of available devices for prehospital teams. Funders have no role in the ACE study.

    • Competing interests None declared.

    • Patient consent for publication Not required.

    • Ethics approval The ACE trial has been approved by the ethics committee (Comité de Protection des Personnes 'Ile de France II' France, 2018-AO1491-54).

    • Provenance and peer review Not commissioned; externally peer reviewed.