DOuble SEquential External Defibrillation for Refractory VF (DOSEVF)

• ClinicalTrials.gov Identifier: NCT04080986
• Recruitment Status: Recruiting
• First Posted: September 6, 2019
• Last Update Posted: March 14, 2022
• Sponsor: Sunnybrook Health Sciences Centre
• Collaborators: Peel Regional Paramedic Services; Toronto Paramedic Services; Halton Region Paramedic Services; County of Simcoe Paramedic Services; London Health Sciences Centre; Middlesex-London EMS; Ottawa Paramedic Service
• Information provided by (Responsible Party): Sunnybrook Health Sciences Centre

Study Description

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, 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 (n=6 crossover periods).

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 420 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: May 2022
• Estimated Study Completion Date: September 2022

Arms and Interventions

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.

Outcome Measures

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. Neurologic outcome [ Time Frame: Throughout study completion of three years ]
   Neurologic outcome as defined by the modified Rankin Scale at time of hospital discharge. mRS 0-2 will be considered a good neurologic outcome.
2. Return of Spontaneous Circulation [ Time Frame: 1 Day ]
   Binary outcome of whether or not a patient had a return of spontaneous circulation
3. 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
4. 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
5. 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

Eligibility Criteria

• 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.

Contacts and Locations

Contacts

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

Canada, Ontario

Peel Regional Paramedic Service; Completed

Brampton, Ontario, Canada

Middlesex-London Paramedic Service; Completed

London, Ontario, Canada

Halton Region Paramedic Services; Completed

Oakville, Ontario, Canada

Ottawa Paramedic Service; Recruiting

Ottawa, Ontario, Canada

Contact: Christian Vaillancourt, MD 613-798-5555 ext 17012 cvaillancourt@ohri.ca

County of Simcoe Paramedic Services; Completed

Simcoe, Ontario, Canada

Toronto Paramedic Services; Completed

Toronto, Ontario, Canada

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

Ottawa Paramedic Service

Investigators

• Principal Investigator: Sheldon Cheskes, MD; Sunnybrook Centre for Prehospital Medicine

  Study Documents (Full-Text)

Documents provided by Sunnybrook Health Sciences Centre:

Study Protocol and Statistical Analysis Plan  [PDF] June 11, 2021

More Information

Publications:

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.

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.

• Responsible Party: Sunnybrook Health Sciences Centre
• ClinicalTrials.gov Identifier: NCT04080986
• Other Study ID Numbers: DOSEVF RCT
• First Posted: September 6, 2019
• Last Update Posted: March 14, 2022
• Last Verified: February 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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:

Out-of-Hospital Cardiac Arrest; Ventricular Fibrillation; Heart Arrest; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Pathologic Processes