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DOuble SEquential External Defibrillation for Refractory VF (DOSEVF)

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ClinicalTrials.gov Identifier: NCT04080986
Recruitment Status : Recruiting
First Posted : September 6, 2019
Last Update Posted : October 23, 2019
Sponsor:
Collaborators:
Peel Regional Paramedic Services
Toronto Paramedic Services
Halton Region Paramedic Services
County of Simcoe Paramedic Services
London Health Sciences Centre
Middlesex-London EMS
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 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.

Condition or disease Intervention/treatment Phase
Out-Of-Hospital Cardiac Arrest Ventricular Fibrillation Procedure: Double Sequential Defibrillation Procedure: Vector Change 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 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 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 (n=6 crossover periods).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 930 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: This is a cluster randomized trial, with cluster units defined by EMS agency. Each cluster will crossover at six month intervals with a total of six crossover periods occurring for each EMS agency during the study.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: DOuble SEquential External Defibrillation for Refractory Ventricular Fibrillation (DOSEVF) Randomized Controlled Trial
Actual Study Start Date : September 10, 2019
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : September 2022


Arm Intervention/treatment
No Intervention: Standard Arm
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.
Active Comparator: 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 pad placement in anterior-posterior position

Active Comparator: 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 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.




Primary Outcome Measures :
  1. Survival to Hospital Discharge [ Time Frame: Through study completion of three years ]
    Binary outcome of whether the patient was discharged alive from hospital or died prior to discharge.


Secondary Outcome Measures :
  1. Return of Spontaneous Circulation [ Time Frame: 1 Day ]
    Binary outcome of whether or not a patient had a return of spontaneous circulation

  2. 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

  3. VF Termination after 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

  4. Number of defibrillation attempts to achieve Return of spontaneous circulation [ Time Frame: 1 Day ]
    Total number of shocks required to achieve the first return of spontaneous circulation 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 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.

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): NCT04080986


Contacts
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Contact: Sheldon Cheskes, MD 416 667 2200 ext 0 sheldon.cheskes@sunnybrook.ca
Contact: Ian R Drennan, ACP PhD(c) 416 667 2200 ext 0 ian.drennan@sunnybrook.ca

Locations
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Canada, Ontario
Peel Regional Paramedic Service Recruiting
Brampton, Ontario, Canada
Contact: Sheldon Cheskes    416-996-4567    sheldon.cheskes@sunnybrook.ca   
Halton Region Paramedic Services Recruiting
Oakville, Ontario, Canada
Contact: Sheldon Cheskes, MD    416-996-4567    sheldon.cheskes@sunnybrook.ca   
County of Simcoe Paramedic Services Recruiting
Simcoe, Ontario, Canada
Contact: Sheldon Cheskes    416-996-4567    sheldon.cheskes@sunnybrook.ca   
Toronto Paramedic Services Recruiting
Toronto, Ontario, Canada
Contact: Sheldon Cheskes    416-996-4567    sheldon.cheskes@sunnybrook.ca   
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Peel Regional Paramedic Services
Toronto Paramedic Services
Halton Region Paramedic Services
County of Simcoe Paramedic Services
London Health Sciences Centre
Middlesex-London EMS
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: NCT04080986     History of Changes
Other Study ID Numbers: DOSEVF RCT
First Posted: September 6, 2019    Key Record Dates
Last Update Posted: October 23, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sunnybrook Health Sciences Centre:
Resuscitation
Arrhythmia, Cardiac
Heart Diseases
Heart Arrest
Additional relevant MeSH terms:
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Out-of-Hospital Cardiac Arrest
Ventricular Fibrillation
Heart Arrest
Heart Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Pathologic Processes