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DOuble SEquential External Defibrillation for Refractory VF (DOSEVF)

Primary Purpose

Out-Of-Hospital Cardiac Arrest, Ventricular Fibrillation

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Double Sequential Defibrillation
Vector Change Defibrillation
Sponsored by
Sunnybrook Health Sciences Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Out-Of-Hospital Cardiac Arrest focused on measuring Resuscitation, Arrhythmia, Cardiac, Heart Diseases, Heart Arrest

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 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.

Sites / Locations

  • Peel Regional Paramedic Service
  • Middlesex-London Paramedic Service
  • Halton Region Paramedic Services
  • Ottawa Paramedic Service
  • County of Simcoe Paramedic Services
  • Toronto Paramedic Services

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Active Comparator

Active Comparator

Arm Label

Standard Arm

Double Sequential Defibrillation

Vector Change 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. 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.

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.

Outcomes

Primary Outcome Measures

Survival to Hospital Discharge
Binary outcome of whether the patient was discharged alive from hospital or died prior to discharge.

Secondary Outcome Measures

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.
Return of Spontaneous Circulation
Binary outcome of whether or not a patient had a return of spontaneous circulation
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 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
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

Full Information

First Posted
August 30, 2019
Last Updated
September 20, 2022
Sponsor
Sunnybrook Health Sciences Centre
Collaborators
Peel Regional Paramedic Services, Toronto Paramedic Services, Halton Region Paramedic Services, County of Simcoe Paramedic Services, London Health Sciences Centre, Middlesex-London EMS, Ottawa Paramedic Service
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1. Study Identification

Unique Protocol Identification Number
NCT04080986
Brief Title
DOuble SEquential External Defibrillation for Refractory VF
Acronym
DOSEVF
Official Title
DOuble SEquential External Defibrillation for Refractory Ventricular Fibrillation (DOSEVF) Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
September 10, 2019 (Actual)
Primary Completion Date
August 1, 2022 (Actual)
Study Completion Date
August 1, 2022 (Actual)

3. Sponsor/Collaborators

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

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 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.
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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Out-Of-Hospital Cardiac Arrest, Ventricular Fibrillation
Keywords
Resuscitation, Arrhythmia, Cardiac, Heart Diseases, Heart Arrest

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
This is a cluster randomized trial, with cluster units defined by EMS agency. Each cluster will crossover at six month intervals for each EMS agency during the study.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
405 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard Arm
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
Double Sequential Defibrillation
Arm Type
Active Comparator
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.
Arm Title
Vector Change Defibrillation
Arm Type
Active Comparator
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.
Intervention Type
Procedure
Intervention Name(s)
Double Sequential Defibrillation
Intervention Description
Defibrillation using pad placement in anterior-posterior position
Intervention Type
Procedure
Intervention Name(s)
Vector Change Defibrillation
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
Survival to Hospital Discharge
Description
Binary outcome of whether the patient was discharged alive from hospital or died prior to discharge.
Time Frame
Through study completion of three years
Secondary Outcome Measure Information:
Title
Neurologic outcome
Description
Neurologic outcome as defined by the modified Rankin Scale at time of hospital discharge. mRS 0-2 will be considered a good neurologic outcome.
Time Frame
Throughout study completion of three years
Title
Return of Spontaneous Circulation
Description
Binary outcome of whether or not a patient had a return of spontaneous circulation
Time Frame
1 Day
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 after 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 achieve Return of spontaneous circulation
Description
Total number of shocks required to achieve the first return of spontaneous circulation 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 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.
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
Middlesex-London Paramedic Service
City
London
State/Province
Ontario
Country
Canada
Facility Name
Halton Region Paramedic Services
City
Oakville
State/Province
Ontario
Country
Canada
Facility Name
Ottawa Paramedic Service
City
Ottawa
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

Plan to Share IPD
No
Citations:
PubMed Identifier
33243277
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.
Results Reference
background
PubMed Identifier
32084567
Citation
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.
Results Reference
background
PubMed Identifier
36342151
Citation
Cheskes S, Verbeek PR, Drennan IR, McLeod SL, Turner L, Pinto R, Feldman M, Davis M, Vaillancourt C, Morrison LJ, Dorian P, Scales DC. Defibrillation Strategies for Refractory Ventricular Fibrillation. N Engl J Med. 2022 Nov 24;387(21):1947-1956. doi: 10.1056/NEJMoa2207304. Epub 2022 Nov 6.
Results Reference
derived

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DOuble SEquential External Defibrillation for Refractory VF

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