Journal Article

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

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

2018

Overview

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.

• Publisher: BioMed Central,BioMed Central Ltd,Springer Nature B.V,BMC
• Subject: Actigraphy - instrumentation / Attitude of Health Personnel / Biomedicine / Bystander / Cardiac arrest / Cardiopulmonary resuscitation / Cardiopulmonary Resuscitation - instrumentation / Cardiopulmonary Resuscitation - methods / Cardiovascular equipment / Care and treatment / Clinical trials / CPR / Critical illness / Defibrillators / Electric Countershock - instrumentation / Emergency medical care / Emergency medical dispatcher / Emergency medical services / Emergency Medical Services - methods / Emergency Medical Technicians - psychology / Emergency services / Equipment Design / Feedback / Feedback, Psychological / Fire departments / Fires / Health aspects / Health Knowledge, Attitudes, Practice / Health Sciences / Health services / Humans / Intervention / Japan / Lifesaving / Medical equipment / Medicine / Medicine & Public Health / Methods / Multicenter Studies as Topic / Out-of-Hospital Cardiac Arrest - diagnosis / Out-of-Hospital Cardiac Arrest - physiopathology / Out-of-Hospital Cardiac Arrest - therapy / Patients / Randomized Controlled Trials as Topic / Recovery of Function / Signal Processing, Computer-Assisted / Software / Statistics for Life Sciences / Study Protocol / Time Factors / Training / Treatment Outcome