Early Double Sequential Defibrillation in Out of Hospital Cardiac Arrest
NCT ID: NCT07174986
Last Updated: 2026-01-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2/PHASE3
916 participants
INTERVENTIONAL
2025-09-08
2029-12-31
Brief Summary
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The aim of this trial is to assess survival with a double defibrillation strategy initiated as soon as possible among patients with Out of Hospital Cardiac Arrest with initial shockable rhythm and at least one failed standard defibrillation, compared with continued resuscitation using standard defibrillation.
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Detailed Description
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In 2022, one prospective cluster randomized trial showed increased survival among OHCA patients in refractory VF using an alternative defibrillation strategy with either, switching to Anterior-Posterior defibrillation pad placements (A-P) or Double Sequential Defibrillation "DSD", (Using two defibrillators, one in the standard anterior-lateral position (A-L) and one in A-P position and defibrillation in rapid sequence) compared to standard defibrillation pad placement.\[5\] Refractory VF was defined as VF that persisted despite three consecutive defibrillations with defibrillation pads in the standard position.
These results prompted the International Liaison Committee on Resuscitation (ILCOR) to release a statement of treatment recommendation on DSD in March 6, 2023. It suggested that "…either vector change or DSD may be considered for adults with cardiac arrest who remain in VF or pulseless VT despite three defibrillations (weak recommendation, low certainty of evidence)." \[6\] Further, if DSD would be used it should be performed with a methodology similar to that described in the trial by Cheskes et al.
However, several questions remain. Knowledge gaps highlighted in the ILCOR statement included if the results from this one cluster randomized trial could be reproduced in any other setting. Further, since survival is inversely associated with the number of defibrillation shocks, if earlier application of DSD could lead to even higher survival for patients not in refractory VF has never been studied.
Study rationale: In order to evaluate if an early DSD-strategy could benefit all patients with VT/VF after the first shock, including those not in refractory VF, the Double-D trial is designed. If DSD would prove to be superior to standard defibrillation in a broader cardiac arrest population, also among those not in refractory VF, this would have a large impact on how Advanced Cardiac Life Support (ACLS) should be performed.
Design: This is an academic, investigator initiated, open-label pilot study with a randomized controlled trial (RCT) design and 1:1 allocation (1 DSD: 1 standard). Screening for inclusion will be performed in all cardiac arrests by participating EMS units where there are two study-specific defibrillators available on site.
Study population: Adult OHCA patients with pulseless VT/VF at initial rhythm analysis, at least one defibrillation performed in standard A-L position without return of spontaneous circulation (ROSC).
P: Adult patients, 18 years or older, with OHCA, initial shockable rhythm (VT/VF) and, at least, one defibrillation performed in standard position and ongoing CPR (no ROSC).
I: Application of a second defibrillator with pad-placement in the anterior-posterior (A-P) position as early as possible after the first shock and double sequential defibrillation after the following rhythm analysis if the patient is still in VT/VF.
C: Standard defibrillation electrode placement (A-L) and routine defibrillation with one defibrillator after the following rhythm analysis if the patient is still in VT/VF.
O: Primary outcome is 30-day survival.
The trial will be conducted by participating ambulance units attending OHCA´s. These units will perform screening for inclusion, randomization, intervention or control treatment and initial follow up.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Early Double sequential defibrillation
If the patient is randomized to the DSD group, the ambulance crew team will apply the second defibrillator with electrodes placed in the A-P position as soon as possible.
Defibrillation is performed by one person defibrillating both defibrillators in a sequential manner "Double Sequential Defibrillation" (DSD). All consecutive defibrillations will thereafter be performed with the DSD strategy until ROSC, termination of resuscitation or decision to move the patient to hospital.
Double sequential defibirllation
A second defibrillator will be applyed with electrodes placed in the A-P position and defibrillation will be performed with two defibrllators in a sequential manner
Standard defibrillation
If the patient is randomized to the standard defibrillation group, the ambulance crew team will continue Advanced life support in accordance with standard of care and continue to perform standard defibibrillation using one defibrillator. All consecutive defibrillations will thereafter be performed with the standard defibrillation strategy until ROSC, termination of resuscitation or decision to move the patient to hospital.
Standard defibrillation
Standard defibrillation uning one defibrillator
Interventions
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Double sequential defibirllation
A second defibrillator will be applyed with electrodes placed in the A-P position and defibrillation will be performed with two defibrllators in a sequential manner
Standard defibrillation
Standard defibrillation uning one defibrillator
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Obvious pregnancy
* Known preexisting Do Not Attempt Resuscitation order
18 Years
ALL
No
Sponsors
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Swedish Heart Lung Foundation
OTHER
Region Stockholm
OTHER_GOV
Vastra Gotaland Region
OTHER_GOV
Region Halland
OTHER
Laerdal Foundation
OTHER
Gabriel Riva
OTHER
Responsible Party
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Gabriel Riva
Principal Investigator
Principal Investigators
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Gabriel Riva, M.D. Ph.D.
Role: STUDY_DIRECTOR
Center for resuscitation Science. Department of clinical sience and education. Södersjukhuset, Karolinksa Institutet, Stockholm, Sweden
Akil Awad, M.D. Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Center for resuscitation Science. Department of clinical sience and education. Södersjukhuset, Karolinksa Institutet, Stockholm, Sweden
Carl Magnusson, R.N., Ph.D.
Role: STUDY_CHAIR
Shalgrenska University Hospital
Andreas Claesson, R.N. Ph.D.
Role: STUDY_CHAIR
Center for resuscitation Science. Department of clinical sience and education. Södersjukhuset, Karolinksa Institutet, Stockholm, Sweden
Johan Israelsson, R.N. Ph.D.
Role: STUDY_CHAIR
ICARE, Department of Health and Caring Sciences, Linnaeus University
Locations
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Ambulanssjukvården, Region Halland
Halmstad, Halland County, Sweden
Ambulanssjukvården Region Värmland
Karlstad, Värmland County, Sweden
Sjukvården i väster
Alingsås, , Sweden
Emergency medical services, Södra Älvsborgs Sjukhus, Region Västra Götaland
Borås, , Sweden
Prehospital Intensive Care Unit (PIV) AnOPIVA Östra Sjukhuset/SU
Gothenburg, , Sweden
Shalgrenska University Hospital
Gothenburg, , Sweden
Ambulanssjukvården Skaraborgs Sjukhus, Västra Götalandsregionen (SKAS)
Skövde, , Sweden
Emergency medical services NU-Sjukvården, Region Västra Götaland
Trollhättan, , Sweden
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Dnr 2025-03532-01
Identifier Type: OTHER
Identifier Source: secondary_id
CIV-ID-25-01-051015
Identifier Type: -
Identifier Source: org_study_id
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