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NCT Number: NCT06672159

Initial Double Sequential External 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.

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Key information

Conditions

Cardiac Arrest Arrhythmias, Cardiac Cardiovascular Diseases Heart Arrest Heart Diseases Out-Of-Hospital Cardiac Arrest Pathologic Processes Pathological Conditions, Signs and Symptoms Ventricular Fibrillation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St Olavs Hospital

Trondheim, 7030, Norway

Location status: Recruiting

Location contact

Jostein R Brede, MD, PhD

CONTACT

[email protected]

Vegard Nordviste, MD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Two defibrillators

Device

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 defibrillator

Device

Standard OHCA treatment according to existing guidelines.

Primary outcomes

  1. Proportion of patients that survive to hospital admission.

    Time frame: 24 hours

    Number of patients arriving with ROSC in hospital emergency facility.

Secondary outcomes

  1. Proportion of patients that survive for 30 days

    Time frame: 30 days

    Number of patients that have survived OHCA incident after 30 days.

  2. Review of 30 day neurological status.

    Time frame: 30 days

    Modified Rankin Scale (1 No significant disability - 5 Severe disability) defines neurological outcome of OHCA.

  3. Proportion of patients that survive for 90 days

    Time frame: 90 days

    Number of patients that have survived OHCA incident after 90 days.

  4. Review 90 day neurological status.

    Time frame: 90 days

    Modified Rankin Scale (1 No significant disability - 5 Severe disability) defines neurological outcome of OHCA.

  5. Proportion of patients that survive for one year.

    Time frame: 365 days

    Number of patients that have survived OHCA incident after 365 days.

Other outcomes

  1. Incidence of patient-related adverse effects.

    Time frame: 365 days

    Measure/obtain information regarding adverse effects experience by patient using DSED procedure.

  2. Incidence of malfunction of defibrillator.

    Time frame: 365 days

    Assess information regarding occurrence of defibrillator damage after DSED procedure.

Study contacts

Contact information is provided by the study sponsor or research team.

Jostein R Brede, MD

CONTACT

[email protected]

+47 99445914

Vegard Nordviste, MD, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

St. Olavs Hospital

Other

Collaborators

  • Norwegian Air Ambulance Foundation

Registry information

Official study title

A Randomized Controlled Trial on Early Double External Sequential Defibrillation in Out of Hospital Cardiac Arrest

Acronym: DUALDEFIB

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Nov 4, 2024
Registry last updated
Jul 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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