DOuble SEquential External Defibrillation for Refractory VF Pilot Study

NCT03249948 | Completed DMC

• 1 other identifier: DOSE-VF-PILOT
• Study Type: interventional
• Target: 173
• Locations: 1 country
• Sites: 4

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 a viable option for patients in refractory VF. This pilot 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 pilot study will provide critical data for planning a larger, adequately powered multi-site randomized controlled trial to clinically evaluate DSED and vector change defibrillation compared to standard therapy for patients in refractory VF.

Conditions

Ventricular Fibrillation

Outcome Measures

Primary Outcomes (2)

• Return of spontaneous circulation (ROSC)

  Binary outcome of whether or not patient returned to spontaneous circulation

  1 day

• Feasibility of double sequential external defibrillation

  80% or greater of patients receiving proper randomization and 80% or greater receiving an intervention shock prior to shock 6

  Day 1

Secondary Outcomes (3)

• VF termination after first interventional shock

  1 day

• VF termination inclusive of all interventional shocks

  1 day

• Number of defibrillation attempts to obtain ROSC

  1 day

Study Arms (3)

Standard defibrillation

NO INTERVENTION

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

OTHER

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

Double-sequential defibrillation

OTHER

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

Interventions

Vector change defibrillation PROCEDURE

Defibrillation using pad placement in anterior-posterior position.

Vector change defibrillation

Double-sequential 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.

Also known as: Double sequential external defibrillation, DSED

Double-sequential defibrillation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥18 years of age, non-traumatic cardiac arrest of presumed cardiac etiology, presenting rhythm to EMS of ventricular fibrillation; no ROSC or non VF rhythm after three consecutive EMS shocks.

You may not qualify if:

• Traumatic cardiac arrest, patients with pre-existing do not resuscitate orders, presumed pregnancy, patients in recurrent ventricular fibrillation (defined as those with a secondary presentation of VF (not the presenting rhythm) or those presenting in VF but did not receive three consecutive defibrillation attempts).

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead
• Peel Regional Paramedic Service: collaborator
• Toronto Paramedic Services: collaborator
• Halton Region Paramedic Services: collaborator
• County of Simcoe Paramedic Services: collaborator

Study Sites (4)

Peel Regional Paramedic Service

Brampton, Ontario, Canada

Location

Halton Region Paramedic Services

Oakville, Ontario, Canada

Location

County of Simcoe Paramedic Services

Simcoe, Ontario, Canada

Location

Toronto Paramedic Services

Toronto, Ontario, Canada

Location

MeSH Terms

Conditions

Ventricular Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sheldon Cheskes, MD

  Sunnybrook Centre for Prehospital Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 1, 2017
• First Posted: August 15, 2017
• Study Start: March 5, 2018
• Primary Completion: September 10, 2019
• Study Completion: March 12, 2020
• Last Updated: March 18, 2020

Record last verified: 2020-03

Locations

CA (4)