DOuble SEquential External Defibrillation for Refractory VF Pilot Study (DOSE-VF)
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|ClinicalTrials.gov Identifier: NCT03249948|
Recruitment Status : Completed
First Posted : August 15, 2017
Last Update Posted : March 18, 2020
|Condition or disease||Intervention/treatment||Phase|
|Ventricular Fibrillation||Procedure: Vector change defibrillation Procedure: Double-sequential defibrillation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||173 participants|
|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)|
|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|
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.
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.
- Return of spontaneous circulation (ROSC) [ Time Frame: 1 day ]Binary outcome of whether or not patient returned to spontaneous circulation
- 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
- 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 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.
- 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.
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
|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|
|Principal Investigator:||Sheldon Cheskes, MD||Sunnybrook Centre for Prehospital Medicine|