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

Cardiac Arrest Clinical Trial

— DISPATCH  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03633370
• Other study ID #: DISPATCH
• Status: Completed
• Phase: N/A
• Start date: August 27, 2018
• Est. completion date: March 20, 2022

Study information

• Verified date: May 2023
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2481
• Est. completion date: March 20, 2022
• Est. primary completion date: March 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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…)

Related Conditions & MeSH terms

• Cardiac Arrest
• Heart Arrest
• Out-of-Hospital Cardiac Arrest

Intervention

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

Locations

Country	Name	City	State
France	SAMU 80 - CHU Amiens Picardie	Amiens
France	SAMU 74 - CH Annecy Genevois	Annecy
France	SAMU 33 - CHU Hôpital Pellegrin	Bordeaux
France	SAMU 01 - CH Fleyriat	Bourg en bresse
France	SAMU 29 - CHRU La Cavale Blanche	Brest
France	SAMU 73 - Centre Hospitalier Métropôle Savoie	Chambéry
France	SAMU 21 - CHU Dijon	Dijon
France	SAMU 38 - CHU Grenoble Alpes	Grenoble
France	Samu 85 - Chd Les Oudairies	La Roche-sur-Yon
France	SAMU 54 - CHU Nancy	Nancy
France	SAMU 44 - Hôtel Dieu	Nantes
France	SAMU 06 - CHU de Nice	Nice
France	SAMU 42 -CHU Saint-Etienne	Saint-Étienne
France	SAMU 31 - CHU Toulouse	Toulouse
France	SAMU 26 - CH de Valence	Valence

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Bystander's CPR quality	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
Other	Confirmation of cardiac arrest	The dispatcher CA's recognition will be confirmed by EMS on scene	Days 0
Other	Automated External Defibrillator initiated before EMS arrival	Proportion of patients who's benefit to a automated external defibrillator before the EMS arrivals	Day 0
Other	CPR initiation by witness without dispatcher Telephone-CPR	Evaluation of the proportion of patients with CPR initiated before EMS arrival without dispatcher Telephone-CPR	Day 0
Other	CPR initiation by witness with Telephone-CPR	Evaluation of CPR initiated before EMS arrival following Telephone-CPR	Day 0
Other	CPR initiation by app-activated bystanders	Evaluation of CPR initiated by bystanders, who are activated by the geo-localization application	Day 0
Other	Proportion of cardiac arrest correctly identified after dispatch	Assessment of the evolution in CA recognition after the e-learning training	24 months
Primary	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	Survival at 72h after out-of-hospital cardiac arrest	survival at 72h	72 hours
Secondary	Return of Spontaneous Circulation	Proportion of patients who's recovered a spontaneous circulation after CPR	Day 0
Secondary	Survival to hospital admission	Vital status at hospital admission	Day 0
Secondary	Survival to hospital discharge	Vital status at hospital discharge	up to 30 days
Secondary	Survival at 30 days	Vital status at 30 days	30 days
Secondary	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	up to 30 days
Secondary	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.; - 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	30 days
Secondary	First recorded rhythm	First recorded cardiac rhythm by EMS	30 min