DOuble SEquential External Defibrillation for Refractory VF

Out-Of-Hospital Cardiac Arrest Clinical Trial

— DOSEVF  

Official title:

DOuble SEquential External Defibrillation for Refractory Ventricular Fibrillation (DOSEVF) Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04080986
• Other study ID #: DOSEVF RCT
• Status: Completed
• Phase: N/A
• Start date: September 10, 2019
• Est. completion date: August 1, 2022

Study information

• Verified date: September 2022
• Source: Sunnybrook Health Sciences Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 405
• Est. completion date: August 1, 2022
• Est. primary completion date: August 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Out-Of-Hospital Cardiac Arrest
• Ventricular Fibrillation

Intervention

Procedure:
• Double Sequential Defibrillation
Defibrillation using pad placement in anterior-posterior position
• 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.

Locations

Country	Name	City	State
Canada	Peel Regional Paramedic Service	Brampton	Ontario
Canada	Middlesex-London Paramedic Service	London	Ontario
Canada	Halton Region Paramedic Services	Oakville	Ontario
Canada	Ottawa Paramedic Service	Ottawa	Ontario
Canada	County of Simcoe Paramedic Services	Simcoe	Ontario
Canada	Toronto Paramedic Services	Toronto	Ontario

Sponsors (8)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre	County of Simcoe Paramedic Services, Halton Region Paramedic Services, London Health Sciences Centre, Middlesex-London EMS, Ottawa Paramedic Service, Peel Regional Paramedic Services, Toronto Paramedic Services

Country where clinical trial is conducted

Canada, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival to Hospital Discharge	Binary outcome of whether the patient was discharged alive from hospital or died prior to discharge.	Through study completion of three years
Secondary	Neurologic outcome	Neurologic outcome as defined by the modified Rankin Scale at time of hospital discharge. mRS 0-2 will be considered a good neurologic outcome.	Throughout study completion of three years
Secondary	Return of Spontaneous Circulation	Binary outcome of whether or not a patient had a return of spontaneous circulation	1 Day
Secondary	VF termination after first interventional shock	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	1 Day
Secondary	VF Termination after all interventional shocks	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	1 Day
Secondary	Number of defibrillation attempts to achieve Return of spontaneous circulation	Total number of shocks required to achieve the first return of spontaneous circulation during resuscitation, inclusive of the first three standard shocks	1 Day