Cardiac ArrestDUALDEFIBNCT06672159
Initial Double Sequential External Defibrillation in Out of Hospital Cardiac Arrest
A study testing Two defibrillators and One defibrillator in people with Cardiac Arrest and Out-Of-Hospital Cardiac Arrest, run by St. Olavs Hospital at 1 site in Norway.
Trial summary
Double Sequential External Defibrillation (DSED) represents an alternative treatment of refractory ventricular fibrillation (rVF) in out-of-hospital cardiac arrest (OHCA). The procedure consists of two defibrillators that administer shocks at the same time. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrest, Out-Of-Hospital Cardiac Arrest, Ventricular Fibrillation
- What is being tested?
- Two defibrillators and One defibrillator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 356 participants
- Where
- 1 siteNorway
- Study dates
- 28 Apr 2025to Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Patients with out of hospital cardiac arrest presenting with a shockable rhythm
Who cannot join
- Age below 18 years
- Obvious or suspected pregnancy
- Incarcerated patients
- Preexisting do-not-resuscitate order
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Vegard Nordviste, MD, PhD contact
Norway1 site, 1 recruiting
- Recruiting
St Olavs Hospital
Trondheim, 7030
Jostein R Brede, MD, PhD, jostein.brede@norskluftambulanse.no
Vegard Nordviste, MD
About this study
Official title: A Randomized Controlled Trial on Early Double External Sequential Defibrillation in Out of Hospital Cardiac Arrest
Double Sequential External Defibrillation (DSED) represents an alternative treatment of refractory ventricular fibrillation (rVF) in out-of-hospital cardiac arrest (OHCA). The procedure consists of two defibrillators that administer shocks at the same time.
Currently, the procedure is not initiated before at least three failed attempts with one defibrillator. This can delay the potential benefits of establishing DSED earlier in the treatment. Studies have shown that early defibrillation is crucial for survival in OHCA patients, and in 2022, a clinical trial showed that survival in patients treated with DSED was higher compared to standard treatment.
The effect of initiating OHCA treatment is unknown. The DUALDEFIB trial seeks to investigate if treating OHCA patients with DSED as an initial treatment will increase survival and provide improved neurological outcome.
Read the detailed description
The project is investigator-initiated, prospective, two-group randomized controlled trial (RCT). Prior to the RCT, a pilot feasibility trial of 3-4 months will be performed, including three ambulance bases in mid-Norway. All OHCA patients will be included until validity and feasibility of the study is accomplished. The pilot study will be followed by the RCT.
Outcome measurements in the RCT are aimed to be the same as in the pilot study. Ambulance bases will be randomized to either DSED or standard procedure for six months before crossover with the other treatment for six months.
Ambulances included in the project will carry two defibrillators. Both defibrillators will be established for initial defibrillation with DSED in OHCA patients. The pads are placed in anterior-lateral position (standard placement) and anterior-posterior position (over sternum and beneath left scapula). Shocks are administered in rapid succession with less than one second apart. All other treatment will be according to existing guidelines.
The included patients are OHCA patients with age over 18 years presenting with a shockable rhythm. Excluded patients are patients with obvious or suspected pregnancy, incarcerated patients or patients with no-resuscitation order. The patients that meet the inclusion criteria will be registered by the ambulance personnel through a secure webpage.
Primary outcome is survival to hospital admission.
Secondary outcomes are survival to hospital discharge, 30 days, 90 days and 1 year survival, in addition to neurological status.
Patients from the pilot will be included in the RCT intervention group.
- Being tested
- Two defibrillators, One defibrillator
- Keywords
- Double defibrillation, Cardiopulmonary resuscitation
- Medical subject headings
- Heart Arrest, Out-of-Hospital Cardiac Arrest, Ventricular Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Two defibrillatorsDevice
DSED procedure consists of pads placed in anterior-lateral position, and in anterior-posterior position. Defibrillations will be given in rapid sequence, less than a second apart. All other aspects of resuscitation in accordance to existing guidelines.
One defibrillatorDevice
Standard OHCA treatment according to existing guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Double sequential external defibrillation | Experimental | Patient will receive first shock using two defibrillators. All other aspects of resuscitation in accordance to existing guidelines. Receives: Device: Two defibrillators |
| Standard treatment | Active comparator | Standard treatment in accordance to existing Advanced Cardiopulmonary Resuscitation-guidelines using one defibrillator in anterior-lateral placement. Receives: Device: One defibrillator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients that survive to hospital admission.
Number of patients arriving with ROSC in hospital emergency facility.
Measured: 24 hours
Secondary outcomes (5)
Proportion of patients that survive for 30 days
Number of patients that have survived OHCA incident after 30 days.
Measured: 30 days
Review of 30 day neurological status.
Modified Rankin Scale (1 No significant disability - 5 Severe disability) defines neurological outcome of OHCA.
Measured: 30 days
Proportion of patients that survive for 90 days
Number of patients that have survived OHCA incident after 90 days.
Measured: 90 days
Review 90 day neurological status.
Modified Rankin Scale (1 No significant disability - 5 Severe disability) defines neurological outcome of OHCA.
Measured: 90 days
Proportion of patients that survive for one year.
Number of patients that have survived OHCA incident after 365 days.
Measured: 365 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2024
- Study start28 Apr 2025
- Primary completionJun 2028 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac ArrestStudies of the same condition, open and under way.
- More trials run by St. Olavs HospitalThe sponsor's other registered studies.
- 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
- All included ambulance stations will perform one of the two procedures for six months followed by a crossover for six months.
- Masking
- None (open label)
- Enrolment
- 356 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Olavs Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian Air Ambulance Foundation
- Responsible party
- Sponsor
- Investigators
- Kjetil Karlsen, Study director, St. Olavs Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06672159
- Sponsor's protocol ID
- 724951
- Acronym
- DUALDEFIB
- Status last verified
- Jul 2026
- First submitted
- 30 Oct 2024
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The full study protocol, statistical analysis plan, information letter for consent and other trial documents will be published open access. The clinical study report and statistical analysis report will also be made openly available but may be altered to hide information that may lead to identification of individual study participants.
Publications
Cheskes S, Drennan IR, Turner L, Pandit SV, Walker RG, Dorian P. The impact of alternate defibrillation strategies on time in ventricular fibrillation. Resuscitation. 2025 Apr;209:110549. doi: 10.1016/j.resuscitation.2025.110549. Epub 2025 Feb 17.
PubMed 39970979
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial on Early Double External Sequential Defibrillation in Out of Hospital Cardiac Arrest
- ClinicalTrials.gov ID
- NCT06672159
- Acronym / sponsor ID
- DUALDEFIB / 724951
- Keywords
- Double defibrillation, Cardiopulmonary resuscitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 356 participants (estimated)
- Lead sponsor
- St. Olavs HospitalUniversity, hospital or other
- Collaborators
- Norwegian Air Ambulance Foundation
- Study start
- 28 Apr 2025 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 4 Nov 2024 (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.
Double Sequential External Defibrillation (DSED) represents an alternative treatment of refractory ventricular fibrillation (rVF) in out-of-hospital cardiac arrest (OHCA). The procedure consists of two defibrillators that administer shocks at the same time.
Currently, the procedure is not initiated before at least three failed attempts with one defibrillator. This can delay the potential benefits of establishing DSED earlier in the treatment. Studies have shown that early defibrillation is crucial for survival in OHCA patients, and in 2022, a clinical trial showed that survival in patients treated with DSED was higher compared to standard treatment.
The effect of initiating OHCA treatment is unknown. The DUALDEFIB trial seeks to investigate if treating OHCA patients with DSED as an initial treatment will increase survival and provide improved neurological outcome.
Detailed description
The project is investigator-initiated, prospective, two-group randomized controlled trial (RCT). Prior to the RCT, a pilot feasibility trial of 3-4 months will be performed, including three ambulance bases in mid-Norway. All OHCA patients will be included until validity and feasibility of the study is accomplished. The pilot study will be followed by the RCT.
Outcome measurements in the RCT are aimed to be the same as in the pilot study. Ambulance bases will be randomized to either DSED or standard procedure for six months before crossover with the other treatment for six months.
Ambulances included in the project will carry two defibrillators. Both defibrillators will be established for initial defibrillation with DSED in OHCA patients. The pads are placed in anterior-lateral position (standard placement) and anterior-posterior position (over sternum and beneath left scapula). Shocks are administered in rapid succession with less than one second apart. All other treatment will be according to existing guidelines.
The included patients are OHCA patients with age over 18 years presenting with a shockable rhythm. Excluded patients are patients with obvious or suspected pregnancy, incarcerated patients or patients with no-resuscitation order. The patients that meet the inclusion criteria will be registered by the ambulance personnel through a secure webpage.
Primary outcome is survival to hospital admission.
Secondary outcomes are survival to hospital discharge, 30 days, 90 days and 1 year survival, in addition to neurological status.
Patients from the pilot will be included in the RCT intervention group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- All included ambulance stations will perform one of the two procedures for six months followed by a crossover for six months.
| Arm | Type | Receives |
|---|---|---|
| Double sequential external defibrillation | Experimental | Device: Two defibrillatorsPatient will receive first shock using two defibrillators. All other aspects of resuscitation in accordance to existing guidelines. |
| Standard treatment | Active comparator | Device: One defibrillatorStandard treatment in accordance to existing Advanced Cardiopulmonary Resuscitation-guidelines using one defibrillator in anterior-lateral placement. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with out of hospital cardiac arrest presenting with a shockable rhythm
Key exclusion criteria (4 listed)
- Age below 18 years
- Obvious or suspected pregnancy
- Incarcerated patients
- Preexisting do-not-resuscitate order
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 |
|---|---|---|
| Two defibrillatorsDSED procedure consists of pads placed in anterior-lateral position, and in anterior-posterior position. Defibrillations will be given in rapid sequence, less than a second apart. All other aspects of resuscitation in accordance to existing guidelines. | Device | Double sequential external defibrillation |
| One defibrillatorStandard OHCA treatment according to existing guidelines. | Device | Standard treatment |
Primary outcome
Proportion of patients that survive to hospital admission.
Time frame: 24 hours
Number of patients arriving with ROSC in hospital emergency facility.
5 secondary outcomes
Proportion of patients that survive for 30 days
Time frame: 30 days
Review of 30 day neurological status.
Time frame: 30 days
Proportion of patients that survive for 90 days
Time frame: 90 days
Review 90 day neurological status.
Time frame: 90 days
Proportion of patients that survive for one year.
Time frame: 365 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- Derived from this study: PubMed 39970979Cheskes S, Drennan IR, Turner L, Pandit SV, Walker RG, Dorian P. The impact of alternate defibrillation strategies on time in ventricular fibrillation. Resuscitation. 2025 Apr;209:110549. doi: 10.1016/j.resuscitation.2025.110549. Epub 2025 Feb 17.
- Individual participant dataSharing planned: Yes. The full study protocol, statistical analysis plan, information letter for consent and other trial documents will be published open access. The clinical study report and statistical analysis report will also be made openly available but may be altered to hide information that may lead to identification of individual study participants.
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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.
Vegard Nordviste, MD, PhD contact
Kjetil Karlsen study director
St. Olavs Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Two defibrillators and One defibrillator in people with Cardiac Arrest and Out-Of-Hospital Cardiac Arrest, run by St. Olavs Hospital at 1 site in Norway.
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 4 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: looking for participants now, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jostein R Brede, MD (+47 99445914, jostein.brede@norskluftambulanse.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients that survive to hospital admission. (time frame: 24 hours). 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 NCT06672159, which also lists 1 linked publication.
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 21 Jul 2026.