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Initial Double Sequential External Defibrillation in Out of Hospital Cardiac Arrest

NCT06672159 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 356

Last updated 2025-06-05

No results posted yet for this study

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.

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.

Conditions

  • Cardiac Arrest
  • Out-Of-Hospital Cardiac Arrest
  • Ventricular Fibrillation

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.

Sponsors & Collaborators

  • Norwegian Air Ambulance Foundation

    collaborator OTHER

  • St. Olavs Hospital

    lead OTHER

Principal Investigators

  • Kjetil Karlsen · St. Olavs Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-28
Primary Completion
2028-06-30
Completion
2028-10-31

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06672159 on ClinicalTrials.gov