Multifaceted Intervention for Increasing Performance of CPR by Laypersons in Out-of-hospital Cardiac Arrest (DISPATCH)
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| ClinicalTrials.gov Identifier: NCT03633370 |
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Recruitment Status :
Recruiting
First Posted : August 16, 2018
Last Update Posted : December 1, 2020
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Cardiac Arrest | Other: Multifaceted intervention including 3 components | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 2084 participants |
| Allocation: | Randomized |
| Intervention Model: | Sequential Assignment |
| Intervention Model Description: | A Stepped Wedge Cluster Randomized Controlled Trial |
| Masking: | Single (Outcomes Assessor) |
| Primary Purpose: | Treatment |
| 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 |
| Actual Study Start Date : | August 27, 2018 |
| Estimated Primary Completion Date : | January 1, 2022 |
| Estimated Study Completion Date : | March 20, 2022 |
| Arm | Intervention/treatment |
|---|---|
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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
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Test Group
Multifaceted intervention
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Other: Multifaceted intervention including 3 components
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 |
- 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.
- Survival at 72h after out-of-hospital cardiac arrest [ Time Frame: 72 hours ]survival at 72h
- Return of Spontaneous Circulation [ Time Frame: Day 0 ]Proportion of patients who's recovered a spontaneous circulation after CPR
- Survival to hospital admission [ Time Frame: Day 0 ]Vital status at hospital admission
- Survival to hospital discharge [ Time Frame: up to 30 days ]Vital status at hospital discharge
- Survival at 30 days [ Time Frame: 30 days ]Vital status at 30 days
- 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
- 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.
- - No significant disability. Able to carry out all usual activities, despite some symptoms.
- - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
- - Moderate disability. Requires some help, but able to walk unassisted.
- - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
- - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
- - Dead Score less or equal to 3 will be considered as favorable neurological outcome
- First recorded rhythm [ Time Frame: 30 min ]First recorded cardiac rhythm by EMS
- 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.
- Confirmation of cardiac arrest [ Time Frame: Days 0 ]The dispatcher CA's recognition will be confirmed by EMS on scene
- 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
- CPR initiation by witness without dispatcher Telephone-CPR [ Time Frame: Day 0 ]Evaluation of the proportion of patients with CPR initiated before EMS arrival without dispatcher Telephone-CPR
- CPR initiation by witness with Telephone-CPR [ Time Frame: Day 0 ]Evaluation of CPR initiated before EMS arrival following Telephone-CPR
- CPR initiation by app-activated bystanders [ Time Frame: Day 0 ]Evaluation of CPR initiated by bystanders, who are activated by the geo-localization application
- 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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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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…)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03633370
| Contact: Guillaume Debaty, MD, PhD | 0033476634202 | gdebaty@chu-grenoble.fr | |
| Contact: Cyrielle Clapé, PhD | 0033476634202 | cclape@chu-grenoble.fr |
| France | |
| SAMU 80 - CHU Amiens Picardie | Recruiting |
| Amiens, France, 80054 | |
| Contact: Christophe Boyer, MD boyer.christophe@chu-amiens.fr | |
| SAMU 74 - CH Annecy Genevois | Completed |
| Annecy, France, 74370 | |
| SAMU 33 - CHU Hôpital Pellegrin | Recruiting |
| Bordeaux, France, 33076 | |
| Contact: Catherine Pradeau, MD, PhD mcatherine.pradeau@chu-bordeaux.fr | |
| SAMU 01 - CH Fleyriat | Completed |
| Bourg en bresse, France, 01012 | |
| SAMU 29 - CHRU La Cavale Blanche | Active, not recruiting |
| Brest, France, 29609 | |
| SAMU 73 - Centre Hospitalier Métropôle Savoie | Recruiting |
| Chambéry, France, 73011 | |
| Contact: Heidi Mampe-Armstrong, MD heidi.mampe@ch-metropole-savoie.fr | |
| SAMU 21 - CHU Dijon | Recruiting |
| Dijon, France, 21000 | |
| Contact: Aurélie Avondo, MD aurelie.avondo@chu-dijon.fr | |
| SAMU 38 - CHU Grenoble Alpes | Completed |
| Grenoble, France, 38043 | |
| Samu 85 - Chd Les Oudairies | Completed |
| La Roche-sur-Yon, France, 85025 | |
| SAMU 54 - CHU Nancy | Recruiting |
| Nancy, France, 54000 | |
| Contact: Tahar Chouihed, MD t.chouihed@gmail.com | |
| SAMU 44 - Hôtel Dieu | Completed |
| Nantes, France | |
| SAMU 06 - CHU de Nice | Recruiting |
| Nice, France, 06001 | |
| Contact: Didier Giolito, MD giolito.d@chu-nice.fr | |
| SAMU 42 -CHU Saint-Etienne | Recruiting |
| Saint-Étienne, France, 42270 | |
| Contact: Pierre-Alban Guenier, MD pierre-alban.guenier@orange.fr | |
| SAMU 31 - CHU Toulouse | Recruiting |
| Toulouse, France, 31000 | |
| Contact: Vincent Bounes, MD, PhD bounes.v@chu-toulouse.fr | |
| SAMU 26 - CH de Valence | Recruiting |
| Valence, France, 26953 | |
| Contact: Claude Zamour, MD czamour@ch-valence.fr | |
| Study Director: | Monique Sorentino | CHU Grenoble Alpes |
| Responsible Party: | University Hospital, Grenoble |
| ClinicalTrials.gov Identifier: | NCT03633370 |
| Other Study ID Numbers: |
DISPATCH |
| First Posted: | August 16, 2018 Key Record Dates |
| Last Update Posted: | December 1, 2020 |
| Last Verified: | November 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | Study protocol will be submitted for publication. IPD will be shared with other researcher. |
| Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Cardiac Arrest Dispatcher Cardiopulmonary Resuscitation |
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Heart Arrest Out-of-Hospital Cardiac Arrest Heart Diseases Cardiovascular Diseases |