DOuble SEquential External Defibrillation for Refractory VF (DOSEVF)
|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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04080986|
Recruitment Status : Recruiting
First Posted : September 6, 2019
Last Update Posted : March 14, 2022
|Condition or disease||Intervention/treatment||Phase|
|Out-Of-Hospital Cardiac Arrest Ventricular Fibrillation||Procedure: Double Sequential Defibrillation Procedure: Vector Change Defibrillation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||420 participants|
|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)|
|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|
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.
- 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.
- 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.
- Return of Spontaneous Circulation [ Time Frame: 1 Day ]Binary outcome of whether or not a patient had a return of spontaneous circulation
- 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
- 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
- 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
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
|Contact: Sheldon Cheskes, MD||416 667 2200 ext email@example.com|
|Contact: Ian R Drennan, ACP PhD(c)||416 667 2200 ext firstname.lastname@example.org|
|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 email@example.com|
|County of Simcoe Paramedic Services||Completed|
|Simcoe, Ontario, Canada|
|Toronto Paramedic Services||Completed|
|Toronto, Ontario, Canada|
|Principal Investigator:||Sheldon Cheskes, MD||Sunnybrook Centre for Prehospital Medicine|