Out-Of-Hospital Cardiac ArrestDOSEVFNCT04080986
DOuble SEquential External Defibrillation for Refractory VF
A study testing Double Sequential Defibrillation and Vector Change Defibrillation in people with Out-Of-Hospital Cardiac Arrest and Ventricular Fibrillation, run by Sunnybrook Health Sciences Centre at 6 sites in Canada.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Out-Of-Hospital Cardiac Arrest, Ventricular Fibrillation
- What is being tested?
- Double Sequential Defibrillation and Vector Change Defibrillation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 405 participants
- Where
- 6 sitesCanada
- Study dates
- 10 Sep 2019to 1 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 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.
Who cannot join
- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Canada6 sites
Peel Regional Paramedic Service
Brampton, Ontario
Middlesex-London Paramedic Service
London, Ontario
Halton Region Paramedic Services
Oakville, Ontario
Ottawa Paramedic Service
Ottawa, Ontario
County of Simcoe Paramedic Services
Simcoe, Ontario
Toronto Paramedic Services
Toronto, Ontario
About this study
Official title: DOuble SEquential External Defibrillation for Refractory Ventricular Fibrillation (DOSEVF) Randomized Controlled Trial
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.
Read the 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.
- Being tested
- Double Sequential Defibrillation, Vector Change Defibrillation
- Keywords
- Resuscitation, Arrhythmia, Cardiac, Heart Diseases, Heart Arrest
- Medical subject headings
- Out-of-Hospital Cardiac Arrest, Ventricular Fibrillation, Arrhythmias, Cardiac, Heart Diseases, Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Double Sequential DefibrillationProcedure or surgery
Defibrillation using pad placement in anterior-posterior position
Vector Change DefibrillationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard Arm | 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. |
| Double Sequential Defibrillation | Active comparator | 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. Receives: Procedure: Double Sequential Defibrillation |
| Vector Change Defibrillation | Active comparator | 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. Receives: Procedure: Vector Change Defibrillation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival to Hospital Discharge
Binary outcome of whether the patient was discharged alive from hospital or died prior to discharge.
Measured: Through study completion of three years
Secondary outcomes (5)
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.
Measured: Throughout study completion of three years
Return of Spontaneous Circulation
Binary outcome of whether or not a patient had a return of spontaneous circulation
Measured: 1 Day
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
Measured: 1 Day
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
Measured: 1 Day
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
Measured: 1 Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2019
- Study start10 Sep 2019
- Primary completion1 Aug 2022
- Study completion1 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Out-Of-Hospital Cardiac ArrestStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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)
- Enrolment
- 405 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor
- Investigators
- Sheldon Cheskes, MD, Principal investigator, Sunnybrook Centre for Prehospital Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04080986
- Sponsor's protocol ID
- DOSEVF RCT
- Acronym
- DOSEVF
- Status last verified
- Sep 2022
- First submitted
- 30 Aug 2019
- Last updated
- 22 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33243277Cheskes 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.
PubMed 32084567Cheskes S, McLeod SL. Double sequential external defibrillation for refractory ventricular fibrillation: the science, the controversies and the future. J Electrocardiol. 2025 Jul-Aug;91:154046. doi: 10.1016/j.jelectrocard.2025.154046. Epub 2025 Jun 4.
PubMed 40483934Cheskes 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.
PubMed 36342151
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DOuble SEquential External Defibrillation for Refractory Ventricular Fibrillation (DOSEVF) Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04080986
- Acronym / sponsor ID
- DOSEVF / DOSEVF RCT
- Keywords
- Resuscitation, Arrhythmia, Cardiac, Heart Diseases, Heart Arrest
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 405 participants (actual)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- 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
- Study start
- 10 Sep 2019 (actual)
- Primary completion
- 1 Aug 2022 (actual)
- Study completion
- 1 Aug 2022 (actual)
- First posted
- 6 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Standard Arm | 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. |
| Double Sequential Defibrillation | Active comparator | Procedure: Double Sequential DefibrillationThe 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. |
| Vector Change Defibrillation | Active comparator | Procedure: Vector Change DefibrillationThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ≥ 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Double Sequential DefibrillationDefibrillation using pad placement in anterior-posterior position | Procedure or surgery | Double Sequential Defibrillation |
| Vector Change DefibrillationDefibrillation 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. | Procedure or surgery | Vector Change Defibrillation |
Primary outcome
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.
5 secondary outcomes
Neurologic outcome
Time frame: Throughout study completion of three years
Return of Spontaneous Circulation
Time frame: 1 Day
VF termination after first interventional shock
Time frame: 1 Day
VF Termination after all interventional shocks
Time frame: 1 Day
Number of defibrillation attempts to achieve Return of spontaneous circulation
Time frame: 1 Day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2022.
- Background: PubMed 33243277Drennan 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.
- Background: PubMed 32084567Cheskes 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.
- Derived from this study: PubMed 40483934Cheskes S, McLeod SL. Double sequential external defibrillation for refractory ventricular fibrillation: the science, the controversies and the future. J Electrocardiol. 2025 Jul-Aug;91:154046. doi: 10.1016/j.jelectrocard.2025.154046. Epub 2025 Jun 4.
- Derived from this study: PubMed 36342151Cheskes 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sheldon Cheskes, MD principal investigator
Sunnybrook Centre for Prehospital Medicine
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Double Sequential Defibrillation and Vector Change Defibrillation in people with Out-Of-Hospital Cardiac Arrest and Ventricular Fibrillation, run by Sunnybrook Health Sciences Centre at 6 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival to Hospital Discharge (time frame: Through study completion of three years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04080986, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2022.