- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03633370
Multifaceted Intervention for Increasing Performance of CPR by Laypersons in Out-of-hospital Cardiac Arrest (DISPATCH)
Multifaceted Intervention for Increasing Performance of Cardiopulmonary Resuscitation by Laypersons in Out-of-hospital Cardiac Arrest. A Stepped Wedge Cluster Randomized Controlled Trial
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Amiens, France, 80054
- SAMU 80 - CHU Amiens Picardie
-
Annecy, France, 74370
- SAMU 74 - CH Annecy Genevois
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Bordeaux, France, 33076
- SAMU 33 - CHU Hôpital Pellegrin
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Bourg en bresse, France, 01012
- SAMU 01 - CH Fleyriat
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Brest, France, 29609
- SAMU 29 - CHRU La Cavale Blanche
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Chambéry, France, 73011
- SAMU 73 - Centre Hospitalier Métropôle Savoie
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Dijon, France, 21000
- SAMU 21 - CHU Dijon
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Grenoble, France, 38043
- SAMU 38 - CHU Grenoble Alpes
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La Roche-sur-Yon, France, 85025
- Samu 85 - Chd Les Oudairies
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Nancy, France, 54000
- SAMU 54 - CHU Nancy
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Nantes, France
- SAMU 44 - Hôtel Dieu
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Nice, France, 06001
- SAMU 06 - CHU de Nice
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Saint-Étienne, France, 42270
- SAMU 42 -CHU Saint-Etienne
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Toulouse, France, 31000
- SAMU 31 - CHU Toulouse
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Valence, France, 26953
- SAMU 26 - CH de Valence
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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…)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control Group
Usual management of patients according to international guidelines.
Protocols of call acceptance, phone advice and sending of emergency services are not modified
|
|
Other: Test Group
Multifaceted intervention
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
CPR initiated by bystanders before the arrival of first professionals rescuers
Time Frame: Day 0
|
Proportion of patients who's received CPR initiated by bystander before EMS arrival.
|
Day 0
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Survival to hospital discharge
Time Frame: up to 30 days
|
Vital status at hospital discharge
|
up to 30 days
|
Survival at 30 days
Time Frame: 30 days
|
Vital status at 30 days
|
30 days
|
Survival at 72h after out-of-hospital cardiac arrest
Time Frame: 72 hours
|
survival at 72h
|
72 hours
|
Return of Spontaneous Circulation
Time Frame: Day 0
|
Proportion of patients who's recovered a spontaneous circulation after CPR
|
Day 0
|
Survival to hospital admission
Time Frame: Day 0
|
Vital status at hospital admission
|
Day 0
|
Neurological functional status CPC
Time Frame: up to 30 days
|
As measured by Cerebral Performance Category (CPC) at hospital discharge and at 30 days Score less or equal to 2 will be considered as favorable neurological outcome
|
up to 30 days
|
Neurological functional status mRS
Time Frame: 30 days
|
As measured by modified Rankin Scale (mRS) at hospital discharge and at 30 days: modified Rankin Scale (mRS): 0 - No symptoms.
|
30 days
|
First recorded rhythm
Time Frame: 30 min
|
First recorded cardiac rhythm by EMS
|
30 min
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Bystander's CPR quality
Time Frame: Day 0
|
Evaluation of CPR quality performed by bystanders on a 4 points scale.
CPR quality will be assessed by first professional rescuers on scene.
|
Day 0
|
Confirmation of cardiac arrest
Time Frame: Days 0
|
The dispatcher CA's recognition will be confirmed by EMS on scene
|
Days 0
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Automated External Defibrillator initiated before EMS arrival
Time Frame: Day 0
|
Proportion of patients who's benefit to a automated external defibrillator before the EMS arrivals
|
Day 0
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CPR initiation by witness without dispatcher Telephone-CPR
Time Frame: Day 0
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Evaluation of the proportion of patients with CPR initiated before EMS arrival without dispatcher Telephone-CPR
|
Day 0
|
CPR initiation by witness with Telephone-CPR
Time Frame: Day 0
|
Evaluation of CPR initiated before EMS arrival following Telephone-CPR
|
Day 0
|
CPR initiation by app-activated bystanders
Time Frame: Day 0
|
Evaluation of CPR initiated by bystanders, who are activated by the geo-localization application
|
Day 0
|
Proportion of cardiac arrest correctly identified after dispatch
Time Frame: 24 months
|
Assessment of the evolution in CA recognition after the e-learning training
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24 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Monique Sorentino, CHU Grenoble Alpes
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DISPATCH
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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