Initial Double Sequential External Defibrillation in Out of Hospital Cardiac Arrest
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Two defibrillators, One defibrillator.
- Who it may be relevant to
- Registry conditions: Cardiac Arrest, Out-Of-Hospital Cardiac Arrest, Ventricular Fibrillation. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Norway
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Randomized Controlled Trial on Early Double External Sequential Defibrillation in Out of Hospital Cardiac Arrest
Overview
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.
Interventions
- Device Two defibrillators
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. - Device One defibrillator
Standard OHCA treatment according to existing guidelines.
Primary outcome measures
- Proportion of patients that survive to hospital admission. [Time frame: 24 hours]
Secondary outcome measures (5)
- 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]
Eligibility criteria
Inclusion criteria
- Patients with out of hospital cardiac arrest presenting with a shockable rhythm
Exclusion criteria
- Age below 18 years
- Obvious or suspected pregnancy
- Incarcerated patients
- Preexisting do-not-resuscitate order
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Norway · 1 center
- St Olavs Hospital — Trondheim
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. PMID 39970979
Identifiers
NCT: NCT06672159 · 724951