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DOuble SEquential External Defibrillation for Refractory VF Pilot Study (DOSE-VF)

Primary Purpose

Ventricular Fibrillation

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Vector change defibrillation
Double-sequential defibrillation
Sponsored by
Sunnybrook Health Sciences Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ventricular Fibrillation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • ≥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.

Exclusion Criteria:

  • 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).

Sites / Locations

  • Peel Regional Paramedic Service
  • Halton Region Paramedic Services
  • County of Simcoe Paramedic Services
  • Toronto Paramedic Services

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Other

Other

Arm Label

Standard defibrillation

Vector change defibrillation

Double-sequential defibrillation

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Return of spontaneous circulation (ROSC)
Binary outcome of whether or not patient returned to spontaneous circulation
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

Secondary Outcome Measures

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.
VF termination inclusive of 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.
Number of defibrillation attempts to obtain ROSC
Total number of shocks required to achieve the first ROSC during resuscitation, inclusive of the first three standard shocks.

Full Information

First Posted
August 1, 2017
Last Updated
March 17, 2020
Sponsor
Sunnybrook Health Sciences Centre
Collaborators
Peel Regional Paramedic Service, Toronto Paramedic Services, Halton Region Paramedic Services, County of Simcoe Paramedic Services
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1. Study Identification

Unique Protocol Identification Number
NCT03249948
Brief Title
DOuble SEquential External Defibrillation for Refractory VF Pilot Study
Acronym
DOSE-VF
Official Title
DOuble SEquential External Defibrillation for Refractory Ventricular Fibrillation - DOSE VF Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
March 5, 2018 (Actual)
Primary Completion Date
September 10, 2019 (Actual)
Study Completion Date
March 12, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sunnybrook Health Sciences Centre
Collaborators
Peel Regional Paramedic Service, Toronto Paramedic Services, Halton Region Paramedic Services, County of Simcoe Paramedic Services

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed 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 a 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 pilot cluster randomized trial will be conducted in the regions of Peel, Halton, Simcoe, and the city of Toronto, Ontario, Canada over a one year period of time. All adult (≥ 18 years) patients presenting in refractory VF (defined as patients presenting in VF and remaining in VF 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, ± antiarrythmic use and epinephrine as per current provincial standard); or (3) resuscitation involving vector change (change of defibrillation pads from anterior-anterior to an anterior-posterior pad position) defibrillation. The cluster units will be defined by emergency medical service (EMS) agency and each cluster will crossover at three times during the trial so that each agency will spend 4 months in each arm of the study. Outcomes of interest will include return of spontaneous circulation (ROSC), termination of VF after the first interventional shock, termination of VF inclusive of all interventional shocks, and number of defibrillation attempts to obtain ROSC. The primary objectives of the pilot study are to determine the feasibility and required sample size of a full-scale RCT in this population.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventricular Fibrillation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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)
Allocation
Randomized
Enrollment
173 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard defibrillation
Arm Type
No Intervention
Arm Description
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.
Arm Title
Vector change defibrillation
Arm Type
Other
Arm Description
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.
Arm Title
Double-sequential defibrillation
Arm Type
Other
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Vector change defibrillation
Intervention Description
Defibrillation using pad placement in anterior-posterior position.
Intervention Type
Procedure
Intervention Name(s)
Double-sequential defibrillation
Other Intervention Name(s)
Double sequential external defibrillation, DSED
Intervention Description
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 Outcome Measure Information:
Title
Return of spontaneous circulation (ROSC)
Description
Binary outcome of whether or not patient returned to spontaneous circulation
Time Frame
1 day
Title
Feasibility of double sequential external defibrillation
Description
80% or greater of patients receiving proper randomization and 80% or greater receiving an intervention shock prior to shock 6
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
VF termination after first interventional shock
Description
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.
Time Frame
1 day
Title
VF termination inclusive of all interventional shocks
Description
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.
Time Frame
1 day
Title
Number of defibrillation attempts to obtain ROSC
Description
Total number of shocks required to achieve the first ROSC during resuscitation, inclusive of the first three standard shocks.
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ≥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. Exclusion Criteria: 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sheldon Cheskes, MD
Organizational Affiliation
Sunnybrook Centre for Prehospital Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peel Regional Paramedic Service
City
Brampton
State/Province
Ontario
Country
Canada
Facility Name
Halton Region Paramedic Services
City
Oakville
State/Province
Ontario
Country
Canada
Facility Name
County of Simcoe Paramedic Services
City
Simcoe
State/Province
Ontario
Country
Canada
Facility Name
Toronto Paramedic Services
City
Toronto
State/Province
Ontario
Country
Canada

12. IPD Sharing Statement

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DOuble SEquential External Defibrillation for Refractory VF Pilot Study

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