Initial Double Sequential External Defibrillation in Out of Hospital Cardiac Arrest

NCT ID: NCT06672159

Last Updated: 2025-06-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 356 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-28
• Study Completion Date: 2028-10-31

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.

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Double sequential external defibrillation

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

Group Type: EXPERIMENTAL

Two defibrillators

Intervention Type: 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.

Standard treatment

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

Group Type: ACTIVE_COMPARATOR

One defibrillator

Intervention Type: DEVICE

Standard OHCA treatment according to existing guidelines.

Interventions

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.

Intervention Type: DEVICE

One defibrillator

Standard OHCA treatment according to existing guidelines.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Norwegian Air Ambulance Foundation

OTHER

Sponsor Role: collaborator

St. Olavs Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kjetil Karlsen

Role: STUDY_DIRECTOR

St. Olavs Hospital

Locations

St Olavs Hospital

Trondheim, , Norway

Site Status: RECRUITING

Countries

Norway

Central Contacts

Jostein R Brede, MD

Role: CONTACT

jostein.brede@norskluftambulanse.no

+47 99445914

Vegard Nordviste, MD, PhD

Role: CONTACT

vegard.nordviste@norskluftambulanse.no

Facility Contacts

Jostein R Brede, MD, PhD

Role: primary

jostein.brede@norskluftambulanse.no

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

724951

Identifier Type: -

Identifier Source: org_study_id