Clinical trial NCT03249948: DOuble SEquential External Defibrillation for Refractory VF Pilot Study
Official title: DOuble SEquential External Defibrillation for Refractory Ventricular Fibrillation - DOSE VF Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ventricular Fibrillation
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
Collaborators: name: Peel Regional Paramedic Service
name: Toronto Paramedic Services
name: Halton Region Paramedic Services
name: County of Simcoe Paramedic Services
First posted: 2017-08-15
Enrollment: 173
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 study, with cluster units defined by EMS agency. Each cluster will crossover at three times during the one year trial so that each agency will spend 4 months in each arm of 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 a viable option for patients in refractory VF. This pilot 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 pilot study will provide critical data for planning a larger, adequately powered multi-site randomized controlled trial to clinically evaluate DSED and vector change defibrillation compared to standard therapy for patients in refractory VF.

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 a 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 pilot cluster randomized trial will be conducted in the regions of Peel, Halton, Simcoe, and the city of Toronto, Ontario, Canada over a one year period of time. All adult (≥ 18 years) patients presenting in refractory VF (defined as patients presenting in VF and remaining in VF 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, ± antiarrythmic use and epinephrine as per current provincial standard); or (3) resuscitation involving vector change (change of defibrillation pads from anterior-anterior to an anterior-posterior pad position) defibrillation. The cluster units will be defined by emergency medical service (EMS) agency and each cluster will crossover at three times during the trial so that each agency will spend 4 months in each arm of the study. Outcomes of interest will include return of spontaneous circulation (ROSC), termination of VF after the first interventional shock, termination of VF inclusive of all interventional shocks, and number of defibrillation attempts to obtain ROSC. The primary objectives of the pilot study are to determine the feasibility and required sample size of a full-scale RCT in this population.

Eligibility criteria: Inclusion Criteria:

* ≥18 years of age, non-traumatic cardiac arrest of presumed cardiac etiology, presenting rhythm to EMS of ventricular fibrillation; no ROSC or non VF rhythm after three consecutive EMS shocks.

Exclusion Criteria:

* Traumatic cardiac arrest, patients with pre-existing do not resuscitate orders, presumed pregnancy, patients in recurrent ventricular fibrillation (defined as those with a secondary presentation of VF (not the presenting rhythm) or those presenting in VF but did not receive three consecutive defibrillation attempts).

Primary outcomes:
measure: Return of spontaneous circulation (ROSC)
timeFrame: 1 day
measure: Feasibility of double sequential external defibrillation
timeFrame: Day 1
Secondary outcomes:
measure: VF termination after first interventional shock
timeFrame: 1 day
measure: VF termination inclusive of all interventional shocks
timeFrame: 1 day
measure: Number of defibrillation attempts to obtain ROSC
timeFrame: 1 day
Other outcomes:
Locations:
city: Brampton
country: Canada
facility: Peel Regional Paramedic Service
state: Ontario
city: Oakville
country: Canada
facility: Halton Region Paramedic Services
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: