Ventricular FibrillationDOSE-VFNCT03249948
DOuble SEquential External Defibrillation for Refractory VF Pilot Study
A study testing Vector change defibrillation and Double-sequential defibrillation in people with Ventricular Fibrillation, run by Sunnybrook Health Sciences Centre at 4 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 a viable option for patients in refractory… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventricular Fibrillation
- What is being tested?
- Vector change defibrillation and Double-sequential defibrillation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 173 participants
- Where
- 4 sitesCanada
- Study dates
- 5 Mar 2018to 12 Mar 2020
- 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 to EMS of ventricular fibrillation; no ROSC or non VF rhythm after three consecutive EMS shocks.
Who cannot join
- 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).
Trial locations and contacts
4 sites in 1 country.
Canada4 sites
Peel Regional Paramedic Service
Brampton, Ontario
Halton Region Paramedic Services
Oakville, 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 - DOSE VF Pilot Study
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.
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 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.
- Conditions
- Ventricular Fibrillation
- Being tested
- Vector change defibrillation, Double-sequential defibrillation
- Medical subject headings
- Ventricular Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vector change defibrillationProcedure or surgery
Defibrillation using pad placement in anterior-posterior position.
Double-sequential defibrillationProcedure or surgery
Also called Double sequential external defibrillation, DSED
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 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. Receives: 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. Receives: Procedure: Double-sequential defibrillation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Return of spontaneous circulation (ROSC)
Binary outcome of whether or not patient returned to spontaneous circulation
Measured: 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
Measured: Day 1
Secondary outcomes (3)
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 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.
Measured: 1 day
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.
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 posted15 Aug 2017
- Study start5 Mar 2018
- Primary completion10 Sep 2019
- Study completion12 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventricular FibrillationStudies 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 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)
- Enrolment
- 173 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Peel Regional Paramedic Service, Toronto Paramedic Services, Halton Region Paramedic Services, County of Simcoe Paramedic Services
- Responsible party
- Sponsor
- Investigators
- Sheldon Cheskes, MD, Principal investigator, Sunnybrook Centre for Prehospital Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03249948
- Sponsor's protocol ID
- DOSE-VF-PILOT
- Acronym
- DOSE-VF
- Status last verified
- Mar 2020
- First submitted
- 1 Aug 2017
- Last updated
- 18 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DOuble SEquential External Defibrillation for Refractory Ventricular Fibrillation - DOSE VF Pilot Study
- ClinicalTrials.gov ID
- NCT03249948
- Acronym / sponsor ID
- DOSE-VF / DOSE-VF-PILOT
- Conditions
- Ventricular Fibrillation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 173 participants (actual)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Collaborators
- Peel Regional Paramedic Service, Toronto Paramedic Services, Halton Region Paramedic Services, County of Simcoe Paramedic Services
- Study start
- 5 Mar 2018 (actual)
- Primary completion
- 10 Sep 2019 (actual)
- Study completion
- 12 Mar 2020 (actual)
- First posted
- 15 Aug 2017 (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 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.
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 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | 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. |
| Double-sequential defibrillation | Other | 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ≥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.
Key exclusion criteria (1 listed)
- 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).
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 |
|---|---|---|
| Vector change defibrillationDefibrillation using pad placement in anterior-posterior position. | Procedure or surgery | Vector change defibrillation |
| Double-sequential defibrillationAlso: Double sequential external defibrillation, DSEDDefibrillation 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 | Double-sequential defibrillation |
Primary outcome
Return of spontaneous circulation (ROSC)
Time frame: 1 day
Binary outcome of whether or not patient returned to spontaneous circulation
Feasibility of double sequential external defibrillation
Time frame: Day 1
80% or greater of patients receiving proper randomization and 80% or greater receiving an intervention shock prior to shock 6
3 secondary outcomes
VF termination after first interventional shock
Time frame: 1 day
VF termination inclusive of all interventional shocks
Time frame: 1 day
Number of defibrillation attempts to obtain ROSC
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 18 Mar 2020.
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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
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vector change defibrillation and Double-sequential defibrillation in people with Ventricular Fibrillation, run by Sunnybrook Health Sciences Centre at 4 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 1 inclusion and 1 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 18 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
Return of spontaneous circulation (ROSC) (time frame: 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Mar 2020.