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

Akihiro Hirakawa,Toshihiro Hatakeyama,Takeyuki Kiguchi,Akiko Kada,Taku Iwami,Takashi Kawamura,Daisuke Kobayashi,Chika Nishiyama

doi:10.1186/s13063-018-2852-8

Abstract

BackgroundThe 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.MethodsEach 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.DiscussionThe 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 registrationUniversity Hospital Medical Information Network (UMIN) Clinical Trials Registry, UMIN000021431. Registered on 11 March 2016.

Highlights

The quality of cardiopulmonary resuscitation (CPR) performed by emergency medical services (EMS) personnel affects patient outcomes after cardiac arrest
In a study evaluating the relationship between the chest compression fraction (CCF) performed by EMS personnel and survival after of-hospital cardiac arrest (OHCA), the proportion of survival to discharge was tripled for CCF of 61– 80% compared with CCF of 0–20% [13]
The purpose of this study is to demonstrate a superiority of the intervention group with real-time feedback, debriefing, and retraining using the CPR feedback device over the control group without real-time feedback, debriefing, and retraining with respect to the primary outcome of 1-month favorable neurological survival in patients with cardiac arrest

Summary

Introduction

The quality of cardiopulmonary resuscitation (CPR) performed by emergency medical services (EMS) personnel affects patient outcomes after cardiac arrest. The main reasons for this suboptimal survival rate are the low proportion of performed bystander CPR/automatic external defibrillator (AED) use and poor quality of CPR, including that by emergency medical services (EMS) providers as reported by previous research [9, 10]. In a study evaluating the relationship between the CCF performed by EMS personnel and survival after OHCA, the proportion of survival to discharge was tripled for CCF of 61– 80% compared with CCF of 0–20% [13]. High-quality CPR is critical to improving survival after cardiac arrest

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