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Completed

NCT Number: NCT04080986

DOuble SEquential External Defibrillation for Refractory VF

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peel Regional Paramedic Service, Brampton, Ontario, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Double Sequential Defibrillation

Procedure

Defibrillation using pad placement in anterior-posterior position

Vector change defibrillation

Procedure

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Sunnybrook Health Sciences Centre

Other

Collaborators

  • 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

Registry information

Official study title

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

Acronym: DOSEVF

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Sep 6, 2019
Registry last updated
Sep 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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