NCT03633370

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,481

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 19, 2018

Completed
28 days until next milestone

First Posted

Study publicly available on registry

August 16, 2018

Completed
11 days until next milestone

Study Start

First participant enrolled

August 27, 2018

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2022

Completed
Last Updated

May 17, 2023

Status Verified

May 1, 2023

Enrollment Period

3.5 years

First QC Date

July 19, 2018

Last Update Submit

May 16, 2023

Conditions

Keywords

Cardiac ArrestDispatcherCardiopulmonary Resuscitation

Outcome Measures

Primary Outcomes (1)

  • CPR initiated by bystanders before the arrival of first professionals rescuers

    Proportion of patients who's received CPR initiated by bystander before EMS arrival.

    Day 0

Secondary Outcomes (8)

  • Survival at 72h after out-of-hospital cardiac arrest

    72 hours

  • Return of Spontaneous Circulation

    Day 0

  • Survival to hospital admission

    Day 0

  • Survival to hospital discharge

    up to 30 days

  • Survival at 30 days

    30 days

  • +3 more secondary outcomes

Other Outcomes (7)

  • Bystander's CPR quality

    Day 0

  • Confirmation of cardiac arrest

    Days 0

  • Automated External Defibrillator initiated before EMS arrival

    Day 0

  • +4 more other outcomes

Study Arms (2)

Control Group

NO INTERVENTION

Usual management of patients according to international guidelines. Protocols of call acceptance, phone advice and sending of emergency services are not modified

Test Group

OTHER

Multifaceted intervention 1. Training using distance learning for medical regulation assistants to recognise cardiac arrest on phone 2. Activation of the location-software application to send bystanders on cardiac arrest location before the arrival of emergency medical services (EMS) 3. Motivation feed-back Volunteers will received feed-back regarding CPR initiated before EMS arrival and survival

Other: Multifaceted intervention including 3 components

Interventions

Multifaceted intervention including Dispatcher training to improve cardiac phone recognition, mobile application to send bystanders on cardiac arrest location before first professionals rescuers and motivational support for volunteer bystanders

Test Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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…)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

SAMU 80 - CHU Amiens Picardie

Amiens, 80054, France

Location

SAMU 74 - CH Annecy Genevois

Annecy, 74370, France

Location

SAMU 33 - CHU Hôpital Pellegrin

Bordeaux, 33076, France

Location

SAMU 01 - CH Fleyriat

Bourg-en-Bresse, 01012, France

Location

SAMU 29 - CHRU La Cavale Blanche

Brest, 29609, France

Location

SAMU 73 - Centre Hospitalier Métropôle Savoie

Chambéry, 73011, France

Location

SAMU 21 - CHU Dijon

Dijon, 21000, France

Location

SAMU 38 - CHU Grenoble Alpes

Grenoble, 38043, France

Location

Samu 85 - Chd Les Oudairies

La Roche-sur-Yon, 85025, France

Location

SAMU 54 - CHU Nancy

Nancy, 54000, France

Location

SAMU 44 - Hôtel Dieu

Nantes, France

Location

SAMU 06 - CHU de Nice

Nice, 06001, France

Location

SAMU 42 -CHU Saint-Etienne

Saint-Etienne, 42270, France

Location

SAMU 31 - CHU Toulouse

Toulouse, 31000, France

Location

SAMU 26 - CH de Valence

Valence, 26953, France

Location

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Monique Sorentino

    CHU Grenoble Alpes

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: A Stepped Wedge Cluster Randomized Controlled Trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2018

First Posted

August 16, 2018

Study Start

August 27, 2018

Primary Completion

March 1, 2022

Study Completion

March 20, 2022

Last Updated

May 17, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will share

Study protocol will be submitted for publication. IPD will be shared with other researcher.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR

Locations