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DOuble SEquential External Defibrillation for Refractory VF Pilot Study (DOSE-VF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03249948
Recruitment Status : Completed
First Posted : August 15, 2017
Last Update Posted : March 18, 2020
Sponsor:
Collaborators:
Peel Regional Paramedic Service
Toronto Paramedic Services
Halton Region Paramedic Services
County of Simcoe Paramedic Services
Information provided by (Responsible Party):
Sunnybrook Health Sciences Centre

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.

Condition or disease Intervention/treatment Phase
Ventricular Fibrillation Procedure: Vector change defibrillation Procedure: Double-sequential defibrillation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 173 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: DOuble SEquential External Defibrillation for Refractory Ventricular Fibrillation - DOSE VF Pilot Study
Actual Study Start Date : March 5, 2018
Actual Primary Completion Date : September 10, 2019
Actual Study Completion Date : March 12, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

Arm Intervention/treatment
No Intervention: Standard defibrillation
All defibrillation attempts will occur using the standard defibrillation method, i.e. defibrillation pads will be placed in the anterior-anterior configuration. The patient may also be administered antiarrythmic agents and epinephrine, as per current provincial standard.
Vector change defibrillation
The first three shocks will occur with defibrillation pads placed in the anterior-anterior position. All further shocks will occur with the pads placed in the anterior-posterior position. The patient may also be administered antiarrythmic agents and epinephrine, as per current provincial standard.
Procedure: Vector change defibrillation
Defibrillation using pad placement in anterior-posterior position.

Double-sequential defibrillation
The first three shocks will occur with defibrillation pads placed in the anterior-anterior position. For all further shocks, a second set of defibrillation pads (via a second on scene EMS or fire defibrillator) will be applied in the anterior-posterior position, and defibrillation will be carried out by sequential defibrillation shocks provided by the two defibrillators (i.e. with a short delay between the two defibrillators). The patient may also be administered antiarrythmic agents and epinephrine, as per current provincial standard.
Procedure: Double-sequential defibrillation
Defibrillation using two defibrillators, one with pad placement in anterior-posterior position, and the other with pad placement in anterior-anterior position, delivering two rapid sequential shocks.
Other Names:
  • Double sequential external defibrillation
  • DSED




Primary Outcome Measures :
  1. Return of spontaneous circulation (ROSC) [ Time Frame: 1 day ]
    Binary outcome of whether or not patient returned to spontaneous circulation

  2. Feasibility of double sequential external defibrillation [ Time Frame: Day 1 ]
    80% or greater of patients receiving proper randomization and 80% or greater receiving an intervention shock prior to shock 6


Secondary Outcome Measures :
  1. VF termination after first interventional shock [ Time Frame: 1 day ]
    Cessation of the VF waveform on defibrillator monitor at first rhythm analysis post interventional or standard shock. The interpretation will occur after three standard shocks have failed to terminate VF.

  2. VF termination inclusive of all interventional shocks [ Time Frame: 1 day ]
    Cessation of the VF waveform on defibrillator monitor at any rhythm analysis post interventional or standard shock. The interpretation will occur after three standard shocks have failed to terminate VF.

  3. Number of defibrillation attempts to obtain ROSC [ Time Frame: 1 day ]
    Total number of shocks required to achieve the first ROSC during resuscitation, inclusive of the first three standard shocks.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

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): NCT03249948


Locations
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Canada, Ontario
Peel Regional Paramedic Service
Brampton, Ontario, Canada
Halton Region Paramedic Services
Oakville, Ontario, Canada
County of Simcoe Paramedic Services
Simcoe, Ontario, Canada
Toronto Paramedic Services
Toronto, Ontario, Canada
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Peel Regional Paramedic Service
Toronto Paramedic Services
Halton Region Paramedic Services
County of Simcoe Paramedic Services
Investigators
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Principal Investigator: Sheldon Cheskes, MD Sunnybrook Centre for Prehospital Medicine

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Responsible Party: Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT03249948    
Other Study ID Numbers: DOSE-VF-PILOT
First Posted: August 15, 2017    Key Record Dates
Last Update Posted: March 18, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Ventricular Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes