Clinical trial NCT03633370: Multifaceted Intervention for Increasing Performance of CPR by Laypersons in Out-of-hospital Cardiac Arrest
Official title: Multifaceted Intervention for Increasing Performance of Cardiopulmonary Resuscitation by Laypersons in Out-of-hospital Cardiac Arrest. A Stepped Wedge Cluster Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Arrest
Keywords: Cardiac Arrest
Dispatcher
Cardiopulmonary Resuscitation
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2018-08-16
Enrollment: 2481
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: A Stepped Wedge Cluster Randomized Controlled Trial
Primary purpose: TREATMENT

Brief summary: Cardiac arrest (CA) early recognition is essential in order to rapidly activate emergency services and for bystanders to begin cardiopulmonary resuscitation (CPR).

As soon as a call is received, EMS dispatchers should try to identify CA. This may be difficult, in a context of stress and distress of the person calling. Yet, it is vital for bystanders to initiate CPR. Survival can be multiplied by 2 to 4 if the bystanders initiate a CPR before the arrival of the emergency medical services.

This work aim to assess a multifaceted intervention combining 3 elements to improve the initial phone recognition of CA and raise the number of patients benefiting from CPR before EMS arrival on scene.

The first element is a dispatcher training to the early phone recognition of CA. This training will be based on the concept of active teaching, favouring the interactive work of learners in particular by listening to real dispatch recordings. It will be completed by continuing education with a distance teaching platform including the systematic listening of recorded CA calls.

The second element is based on the deployment of a software aiming to notify CA thanks to mobile phones. This system interfaced to a control software enables to request the participation of CPR-trained volunteers automatically. The volunteers have to be located in the patient's surroundings. The deployment of this mobile application will rely on first-aid volunteers, health personal and any trained volunteers willing to participate. A randomized control study in one city area proved the efficiency of a similar software to improve the proportion of CPR by bystanders.

The third element consists in a motivational feedback. A weekly overview of the management and the outcomes of patients who suffered CA will be broadcast to all the responders and volunteers in the mobile application.


Eligibility criteria: Inclusion Criteria:

* All adults with nontraumatic, out-of-hospital cardiac arrest diagnosed during the emergency medical service call
* Cardiac arrest located in urban area

Exclusion Criteria:

* Pregnant or breastfeeding women
* Patients under the law
* Patients deprived of liberty by court ruling or administrative ruling
* Traumatic cardiac arrest
* CA occurring under the eyes of a professional emergency services patrol on duty
* Cardiac arrest for which resuscitation seem unjustified (inevitable death, terminally ill irreversible condition, too long duration of cardiac arrest, non-resuscitation personal directive...)

Primary outcomes:
measure: CPR initiated by bystanders before the arrival of first professionals rescuers
timeFrame: Day 0
Secondary outcomes:
measure: Survival at 72h after out-of-hospital cardiac arrest
timeFrame: 72 hours
measure: Return of Spontaneous Circulation
timeFrame: Day 0
measure: Survival to hospital admission
timeFrame: Day 0
measure: Survival to hospital discharge
timeFrame: up to 30 days
measure: Survival at 30 days
timeFrame: 30 days
measure: Neurological functional status CPC
timeFrame: up to 30 days
measure: Neurological functional status mRS
timeFrame: 30 days
measure: First recorded rhythm
timeFrame: 30 min
Other outcomes:
measure: Bystander's CPR quality
timeFrame: Day 0
measure: Confirmation of cardiac arrest
timeFrame: Days 0
measure: Automated External Defibrillator initiated before EMS arrival
timeFrame: Day 0
measure: CPR initiation by witness without dispatcher Telephone-CPR
timeFrame: Day 0
measure: CPR initiation by witness with Telephone-CPR
timeFrame: Day 0
measure: CPR initiation by app-activated bystanders
timeFrame: Day 0
measure: Proportion of cardiac arrest correctly identified after dispatch
timeFrame: 24 months
Locations:
city: Amiens
country: France
facility: SAMU 80 - CHU Amiens Picardie
city: Annecy
country: France
facility: SAMU 74 - CH Annecy Genevois
city: Bordeaux
country: France
facility: SAMU 33 - CHU Hôpital Pellegrin
city: Bourg en bresse
country: France
facility: SAMU 01 - CH Fleyriat
city: Brest
country: France
facility: SAMU 29 - CHRU La Cavale Blanche
city: Chambéry
country: France
facility: SAMU 73 - Centre Hospitalier Métropôle Savoie
city: Dijon
country: France
facility: SAMU 21 - CHU Dijon
city: Grenoble
country: France
facility: SAMU 38 - CHU Grenoble Alpes
city: La Roche-sur-Yon
country: France
facility: Samu 85 - Chd Les Oudairies
city: Nancy
country: France
facility: SAMU 54 - CHU Nancy
city: Nantes
country: France
facility: SAMU 44 - Hôtel Dieu
city: Nice
country: France
facility: SAMU 06 - CHU de Nice
city: Saint-Étienne
country: France
facility: SAMU 42 -CHU Saint-Etienne
city: Toulouse
country: France
facility: SAMU 31 - CHU Toulouse
city: Valence
country: France
facility: SAMU 26 - CH de Valence
Study officials:
affiliation: CHU Grenoble Alpes
name: Monique Sorentino
role: STUDY_DIRECTOR
References: