An interventional study of Two defibrillators and One defibrillator in Cardiac Arrest, Out-Of-Hospital Cardiac Arrest and Ventricular Fibrillation, sponsored by St. Olavs Hospital. Recruiting at 1 site in Norway. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-21.
Sponsored by St. Olavs Hospital · Not applicable, Interventional, and Treatment
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.
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.
314 studies on the registry are indexed under Out-of-Hospital Cardiac Arrest; 93 are open to participants now.
This study's planned enrollment of 356 is above the median of 218 across 179 interventional studies indexed under Out-of-Hospital Cardiac Arrest.
Browse Out-of-Hospital Cardiac Arrest studies →St. Olavs Hospital is the lead sponsor of 171 studies on the registry; 29 are open to participants now.
Compared within Out-of-Hospital Cardiac Arrest, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Heart Arrest. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patient will receive first shock using two defibrillators. All other aspects of resuscitation in accordance to existing guidelines.
Device: Two defibrillators
Standard treatment in accordance to existing Advanced Cardiopulmonary Resuscitation-guidelines using one defibrillator in anterior-lateral placement.
Device: One defibrillator
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.
Standard OHCA treatment according to existing guidelines.
Proportion of patients that survive to hospital admission.
Number of patients arriving with ROSC in hospital emergency facility.
Time frame: 24 hours
Proportion of patients that survive for 30 days
Number of patients that have survived OHCA incident after 30 days.
Time frame: 30 days
Review of 30 day neurological status.
Modified Rankin Scale (1 No significant disability - 5 Severe disability) defines neurological outcome of OHCA.
Time frame: 30 days
Proportion of patients that survive for 90 days
Number of patients that have survived OHCA incident after 90 days.
Time frame: 90 days
Review 90 day neurological status.
Modified Rankin Scale (1 No significant disability - 5 Severe disability) defines neurological outcome of OHCA.
Time frame: 90 days
Proportion of patients that survive for one year.
Number of patients that have survived OHCA incident after 365 days.
Time frame: 365 days
Incidence of patient-related adverse effects.
Measure/obtain information regarding adverse effects experience by patient using DSED procedure.
Time frame: 365 days
Incidence of malfunction of defibrillator.
Assess information regarding occurrence of defibrillator damage after DSED procedure.
Time frame: 365 days
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: Study protocol and ICF will be available before study start. SAP will be available before first interim analysis.
Access criteria: Individual level data will be made available to sponsor institutions. Access will be controlled by a data processor agreement between the partner and funder. De-identified individual level data collected during the trial, will be made available on request to researchers from other scientific institutions by approval of the project management to ensure that usage is compliant with privacy and consent requirements as well as conditions for attribution and usage. Data sharing with editors or peer-reviewers of scientific journals, conferences or the like will not require additional consent or data access agreement with sponsor, as such data will not be shared onward or used beyond reviewing this trial. After data sharing, the sponsor must be acknowledged in any publication resulting from the shared data. For closer collaboration attribution based on the Vancouver Convention will apply.
Started Apr 2025 (actual). Primary completion is estimated for Jun 2028, 38 months after the start.
Of 93 non-industry interventional studies with no phase under Out-of-Hospital Cardiac Arrest, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 57. This study's planned 38 months is above that.
Counting every sponsor, half of 95 studies reached it within 34 months; a quarter within 19 and three quarters within 57.
How these figures are worked out, and which studies are left out of them.
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