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01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Trials 1/2018

Real-time feedback, debriefing, and retraining system of cardiopulmonary resuscitation for out-of-hospital cardiac arrests: a study protocol for a cluster parallel-group randomized controlled trial

Zeitschrift:
Trials > Ausgabe 1/2018
Autoren:
Akihiro Hirakawa, Toshihiro Hatakeyama, Daisuke Kobayashi, Chika Nishiyama, Akiko Kada, Takeyuki Kiguchi, Takashi Kawamura, Taku Iwami
Wichtige Hinweise

Electronic supplementary material

The online version of this article (https://​doi.​org/​10.​1186/​s13063-018-2852-8) contains supplementary material, which is available to authorized users.
Akihiro Hirakawa and Toshihiro Hatakeyama contributed equally to this work.

Abstract

Background

The quality of cardiopulmonary resuscitation (CPR) performed by emergency medical services (EMS) personnel affects patient outcomes after cardiac arrest. A CPR feedback device with an accelerometer mounted on a defibrillator can monitor the motion of the patient’s sternum to display and record CPR quality in real time. To evaluate the utility of real-time feedback, debriefing, and retraining using a CPR feedback device outside of the hospital, an open-label, cluster randomized controlled trial will be conducted in five municipalities of Osaka Prefecture, Japan.

Methods

Each EMS station within a fire department will be randomly assigned to: 1) the treatment group with real-time feedback, debriefing, and retraining using the CPR feedback device (intervention group); or 2) the conventional treatment group without real-time feedback, debriefing, and retraining (control group). This trial will include 2850 to 3020 patients over about 4 years. The primary outcome of the trial is 1-month favorable neurological survival, defined as cerebral performance category scale score 1 or 2. Secondary outcomes are 1-month survival, survival to hospital discharge, return of spontaneous circulation, and quality of CPR including fraction, depth, tempo, and ventilation rate.

Discussion

The trial will assess whether treatment monitored by the CPR feedback device, which allows for real-time feedback, debriefing, and retraining using CPR quality data, outperforms conventional treatment without real-time feedback, debriefing, and retraining in terms of 1-month favorable neurological survival in cardiac arrest patients receiving CPR outside the hospital.

Trial registration

University Hospital Medical Information Network (UMIN) Clinical Trials Registry, UMIN000021431. Registered on 11 March 2016.
Zusatzmaterial
Additional file 1: SPIRIT 2013 Checklist: Recommended items to address in a clinical trial protocol and related documents. (It is strongly recommended that this checklist be read in conjunction with the SPIRIT 2013 Explanation & Elaboration for important clarification on the items. Amendments to the protocol should be tracked and dated. The SPIRIT checklist is copyrighted by the SPIRIT Group under the Creative Commons “Attribution-NonCommercial-NoDerivs 3.0 Unported” license2) (DOC 126 kb)
13063_2018_2852_MOESM1_ESM.doc
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