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Cardiac ArrestDISPATCHNCT03633370

Multifaceted Intervention for Increasing Performance of CPR by Laypersons in Out-of-hospital Cardiac Arrest

A study testing Multifaceted intervention including 3 components in people with Cardiac Arrest, run by University Hospital, Grenoble at 15 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cardiac Arrest
What is being tested?
Multifaceted intervention including 3 components
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,481 participants
Where
15 sitesFrance
Study dates
27 Aug 2018to 20 Mar 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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…)

Trial locations and contacts

15 sites in 1 country.

15 sites in 1 country

France15 sites
  • SAMU 80 - CHU Amiens Picardie

    Amiens, 80054

  • SAMU 74 - CH Annecy Genevois

    Annecy, 74370

  • SAMU 33 - CHU Hôpital Pellegrin

    Bordeaux, 33076

  • SAMU 01 - CH Fleyriat

    Bourg-en-Bresse, 01012

  • SAMU 29 - CHRU La Cavale Blanche

    Brest, 29609

  • SAMU 73 - Centre Hospitalier Métropôle Savoie

    Chambéry, 73011

  • SAMU 21 - CHU Dijon

    Dijon, 21000

  • SAMU 38 - CHU Grenoble Alpes

    Grenoble, 38043

  • Samu 85 - Chd Les Oudairies

    La Roche-sur-Yon, 85025

  • SAMU 54 - CHU Nancy

    Nancy, 54000

  • SAMU 44 - Hôtel Dieu

    Nantes

  • SAMU 06 - CHU de Nice

    Nice, 06001

  • SAMU 42 -CHU Saint-Etienne

    Saint-Etienne, 42270

  • SAMU 31 - CHU Toulouse

    Toulouse, 31000

  • SAMU 26 - CH de Valence

    Valence, 26953

Other trials in France

About this study

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

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.

Read more

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.

Conditions
Cardiac Arrest
Being tested
Multifaceted intervention including 3 components
Keywords
Cardiac Arrest, Dispatcher, Cardiopulmonary Resuscitation
Medical subject headings
Heart Arrest

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Multifaceted intervention including 3 componentsOther

    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

Study groups in NCT03633370
Study groupRoleWhat they receive
Control GroupNo interventionUsual management of patients according to international guidelines. Protocols of call acceptance, phone advice and sending of emergency services are not modified
Test GroupOtherMultifaceted 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
Receives: Other: Multifaceted intervention including 3 components

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Day 0

Secondary outcomes (8)
  1. Survival at 72h after out-of-hospital cardiac arrest

    survival at 72h

    Measured: 72 hours

  2. Return of Spontaneous Circulation

    Proportion of patients who's recovered a spontaneous circulation after CPR

    Measured: Day 0

  3. Survival to hospital admission

    Vital status at hospital admission

    Measured: Day 0

  4. Survival to hospital discharge

    Vital status at hospital discharge

    Measured: up to 30 days

  5. Survival at 30 days

    Vital status at 30 days

    Measured: 30 days

  6. Neurological functional status CPC

    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

    Measured: up to 30 days

  7. Neurological functional status mRS

    As measured by modified Rankin Scale (mRS) at hospital discharge and at 30 days:

    modified Rankin Scale (mRS): 0 - No symptoms.

    1. - No significant disability. Able to carry out all usual activities, despite some symptoms.
    2. - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
    3. - Moderate disability. Requires some help, but able to walk unassisted.
    4. - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
    5. - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
    6. - Dead Score less or equal to 3 will be considered as favorable neurological outcome

    Measured: 30 days

  8. First recorded rhythm

    First recorded cardiac rhythm by EMS

    Measured: 30 min

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Aug 2018
  2. Study start27 Aug 2018
  3. Primary completion1 Mar 2022
  4. Study completion20 Mar 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Model description
A Stepped Wedge Cluster Randomized Controlled Trial
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
2,481 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03633370
Sponsor's protocol ID
DISPATCH
Acronym
DISPATCH
Status last verified
May 2023
First submitted
19 Jul 2018
Last updated
17 May 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Study protocol will be submitted for publication. IPD will be shared with other researcher.

Publications

  • Debaty G, Ribes S, Ray P, Chouihed T, Desseigne N, Usseglio P, Serre P, Pradeau C, Bounes V, Roupioz T, Lucas AS, Giolito D, Zamour C, Boyer C, Hubert H, Savary D, Tazarourte K, Freund Y, Watson SI, Hemming K, Lamhaut L, Labarere J. A multifaceted intervention to increase bystander CPR rates after out-of-hospital cardiac arrest in France: a stepped-wedge, cluster-randomised, controlled trial. Lancet Public Health. 2026 Nov;11(11):e878-e888. doi: 10.1016/S2468-2667(26)00200-8.

    PubMed 42901186

Questions about this trial

What is this clinical trial studying?

A study testing Multifaceted intervention including 3 components in people with Cardiac Arrest, run by University Hospital, Grenoble at 15 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

CPR initiated by bystanders before the arrival of first professionals rescuers (time frame: Day 0). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03633370, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2023.

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DISPATCH Clinical Trial NCT03633370 | AzTrials