Clinical trial NCT04080986: DOuble SEquential External Defibrillation for Refractory VF
Official title: DOuble SEquential External Defibrillation for Refractory Ventricular Fibrillation (DOSEVF) Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Out-Of-Hospital Cardiac Arrest
Ventricular Fibrillation
Keywords: Resuscitation
Arrhythmia, Cardiac
Heart Diseases
Heart Arrest
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
Collaborators: name: Peel Regional Paramedic Services
name: Toronto Paramedic Services
name: Halton Region Paramedic Services
name: County of Simcoe Paramedic Services
name: London Health Sciences Centre
name: Middlesex-London EMS
name: Ottawa Paramedic Service
First posted: 2019-09-06
Enrollment: 405
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This is a cluster randomized trial, with cluster units defined by EMS agency. Each cluster will crossover at six month intervals for each EMS agency during the study.
Primary purpose: TREATMENT

Brief summary: Despite significant advances in resuscitation efforts, there are some patients who remain in refractory ventricular fibrillation (VF) during out-of-hospital cardiac arrest. Double sequential external defibrillation (DSED) and vector change defibrillation have been proposed as viable options for patients in refractory VF. This cluster randomized trial will compare (1) continued resuscitation using standard defibrillation; (2) resuscitation involving DSED; or (3) resuscitation involving vector change defibrillation, in patients presenting with refractory VF during out-of-hospital cardiac arrest. The results of this study will provide high level evidence of the impact of both DSED and vector change defibrillation on ROSC and patient survival after OHCA.

Detailed description: Double sequential external defibrillation (DSED) and vector change defibrillation have been proposed as viable options for patients in refractory ventricular fibrillation (VF) during out-of-hospital cardiac arrest. However, currently there is insufficient evidence to support widespread implementation of this therapy. As such, a well-designed randomized controlled trial (RCT) employing a standardized approach to alternative defibrillation strategies early in the treatment of refractory VF is required to determine whether these treatments may impact clinical outcomes. This cluster randomized trial will be conducted in the regions of Peel, Halton, Simcoe, and the cities of London, Ottawa, and Toronto, Ontario, Canada over a three year time period. All adult (≥ 18 years) patients presenting in refractory VF/pulseless ventricular tachycardia (pVT) (defined as patients presenting in VF/pVT and remaining in VF/pVT after three consecutive standard defibrillation attempts each separated by 2 minutes of CPR) during out-of-hospital cardiac arrest of presumed cardiac etiology will be assigned to be treated by one of three strategies: (1) continued resuscitation using standard defibrillation; (2) resuscitation involving DSED (two defibrillators, one using anterior-posterior pad placement and the second using anterior- anterior pad placement delivering two rapid sequential shocks for all subsequent defibrillation attempts); or (3) resuscitation involving vector change (change of defibrillation pads from anterior-anterior to an anterior-posterior pad position) defibrillation. All study arms will continue to receive antiarrhythmic use and epinephrine as per current provincial standards. The cluster units will be defined by emergency medical service (EMS) agency and each cluster will crossover at 6 month intervals throughout the duration of the study.

Eligibility criteria: Inclusion Criteria:

* ≥ 18 years of age
* Non-traumatic cardiac arrest of presumed cardiac etiology
* Presenting rhythm of ventricular fibrillation or pulseless ventricular tachycardia
* No ROSC or non-shockable rhythm after three consecutive shocks by EMS or fire department.

Exclusion Criteria:

* Traumatic cardiac arrest
* Patients with pre-existing do not resuscitate orders
* Patients without VF or pulseless VT as presenting rhythm
* Patients without three consecutive shocks delivered
* Patients initially treated by non-participating fire or EMS agencies.

Primary outcomes:
measure: Survival to Hospital Discharge
timeFrame: Through study completion of three years
Secondary outcomes:
measure: Neurologic outcome
timeFrame: Throughout study completion of three years
measure: Return of Spontaneous Circulation
timeFrame: 1 Day
measure: VF termination after first interventional shock
timeFrame: 1 Day
measure: VF Termination after all interventional shocks
timeFrame: 1 Day
measure: Number of defibrillation attempts to achieve Return of spontaneous circulation
timeFrame: 1 Day
Other outcomes:
Locations:
city: Brampton
country: Canada
facility: Peel Regional Paramedic Service
state: Ontario
city: London
country: Canada
facility: Middlesex-London Paramedic Service
state: Ontario
city: Oakville
country: Canada
facility: Halton Region Paramedic Services
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Paramedic Service
state: Ontario
city: Simcoe
country: Canada
facility: County of Simcoe Paramedic Services
state: Ontario
city: Toronto
country: Canada
facility: Toronto Paramedic Services
state: Ontario
Study officials:
affiliation: Sunnybrook Centre for Prehospital Medicine
name: Sheldon Cheskes, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Drennan IR, Dorian P, McLeod S, Pinto R, Scales DC, Turner L, Feldman M, Verbeek PR, Morrison LJ, Cheskes S. DOuble SEquential External Defibrillation for Refractory Ventricular Fibrillation (DOSE VF): study protocol for a randomized controlled trial. Trials. 2020 Nov 26;21(1):977. doi: 10.1186/s13063-020-04904-z.
citation: Cheskes S, Dorian P, Feldman M, McLeod S, Scales DC, Pinto R, Turner L, Morrison LJ, Drennan IR, Verbeek PR. Double sequential external defibrillation for refractory ventricular fibrillation: The DOSE VF pilot randomized controlled trial. Resuscitation. 2020 May;150:178-184. doi: 10.1016/j.resuscitation.2020.02.010. Epub 2020 Feb 19.
citation: Cheskes S, Verbeek PR, Drennan IR, McLeod SL, Turner L, Pinto R, Feldman M, Davis M, Vaillancourt C, Morrison LJ, Dorian P, Scales DC. Defibrillation Strategies for Refractory Ventricular Fibrillation. N Engl J Med. 2022 Nov 24;387(21):1947-1956. doi: 10.1056/NEJMoa2207304. Epub 2022 Nov 6.