Initial Double Sequential External Defibrillation in Out of Hospital Cardiac Arrest

NCT06672159 | Recruiting DMC

• 1 other identifier: 724951
• Study Type: interventional
• Target: 356
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Double defibrillation; Cardiopulmonary resuscitation

Outcome Measures

Primary Outcomes (1)

• Proportion of patients that survive to hospital admission.

  Number of patients arriving with ROSC in hospital emergency facility.

  24 hours

Secondary Outcomes (5)

• Proportion of patients that survive for 30 days

  30 days

• Review of 30 day neurological status.

  30 days

• Proportion of patients that survive for 90 days

  90 days

• Review 90 day neurological status.

  90 days

• Proportion of patients that survive for one year.

  365 days

Other Outcomes (2)

• Incidence of patient-related adverse effects.

  365 days

• Incidence of malfunction of defibrillator.

  365 days

Study Arms (2)

Double sequential external defibrillation

EXPERIMENTAL

Patient will receive first shock using two defibrillators. All other aspects of resuscitation in accordance to existing guidelines.

Device: Two defibrillators

Standard treatment

ACTIVE COMPARATOR

Standard treatment in accordance to existing Advanced Cardiopulmonary Resuscitation-guidelines using one defibrillator in anterior-lateral placement.

Device: One defibrillator

Interventions

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.

Double sequential external defibrillation

One defibrillator DEVICE

Standard OHCA treatment according to existing guidelines.

Standard treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with out of hospital cardiac arrest presenting with a shockable rhythm

You may not qualify if:

• Age below 18 years
• Obvious or suspected pregnancy
• Incarcerated patients
• Preexisting do-not-resuscitate order

Sponsors & Collaborators

• St. Olavs Hospital: lead
• Norwegian Air Ambulance Foundation: collaborator

Study Sites (1)

St Olavs Hospital

Trondheim, 7030, Norway

RECRUITING

MeSH Terms

Conditions

Heart Arrest; Out-of-Hospital Cardiac Arrest; Ventricular Fibrillation

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Kjetil Karlsen

  St. Olavs Hospital

  STUDY DIRECTOR

Central Study Contacts

Jostein R Brede, MD

CONTACT

+47 99445914; jostein.brede@norskluftambulanse.no

Vegard Nordviste, MD, PhD

CONTACT

vegard.nordviste@norskluftambulanse.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All included ambulance stations will perform one of the two procedures for six months followed by a crossover for six months.

Study Record Dates

• First Submitted: October 30, 2024
• First Posted: November 4, 2024
• Study Start: April 28, 2025
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): October 1, 2028
• Last Updated: June 5, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• 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.

Locations

NO (1)