Initial Double Sequential External Defibrillation in Out of Hospital Cardiac Arrest (DUALDEFIB)

A Randomized Controlled Trial on Early Double External Sequential 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.

Study Overview

• Status: Recruiting
• Conditions: Ventricular Fibrillation; Cardiac Arrest; Out-Of-Hospital Cardiac Arrest
• Intervention / Treatment: Device: Two defibrillators; Device: One defibrillator

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.

• Study Type: Interventional
• Enrollment (Estimated): 356
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jostein R Brede, MD; Phone Number: +47 99445914; Email: jostein.brede@norskluftambulanse.no
• Study Contact Backup: Name: Vegard Nordviste, MD, PhD; Email: vegard.nordviste@norskluftambulanse.no

Study Locations

• Norway
  • Trondheim, Norway, 7030
    • Recruiting
    • St Olavs hospital
    • Contact: Jostein R Brede, MD, PhD; Email: jostein.brede@norskluftambulanse.no
    • Sub-Investigator: Vegard Nordviste, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Double sequential external defibrillation; Patient will receive first shock using two defibrillators. All other aspects of resuscitation in accordance to existing guidelines.	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.
Active Comparator: Standard treatment; Standard treatment in accordance to existing Advanced Cardiopulmonary Resuscitation-guidelines using one defibrillator in anterior-lateral placement.	Device: One defibrillator; Standard OHCA treatment according to existing guidelines.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients that survive to hospital admission.	Number of patients arriving with ROSC in hospital emergency facility.	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients that survive for 30 days	Number of patients that have survived OHCA incident after 30 days.	30 days
Review of 30 day neurological status.	Modified Rankin Scale (1 No significant disability - 5 Severe disability) defines neurological outcome of OHCA.	30 days
Proportion of patients that survive for 90 days	Number of patients that have survived OHCA incident after 90 days.	90 days
Review 90 day neurological status.	Modified Rankin Scale (1 No significant disability - 5 Severe disability) defines neurological outcome of OHCA.	90 days
Proportion of patients that survive for one year.	Number of patients that have survived OHCA incident after 365 days.	365 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of patient-related adverse effects.	Measure/obtain information regarding adverse effects experience by patient using DSED procedure.	365 days
Incidence of malfunction of defibrillator.	Assess information regarding occurrence of defibrillator damage after DSED procedure.	365 days

Collaborators and Investigators

• Sponsor: St. Olavs Hospital
• Collaborators: Norwegian Air Ambulance Foundation
• Investigators: Study Director: Kjetil Karlsen, St. Olavs Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 28, 2025
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): October 1, 2028

Study Registration Dates

• First Submitted: October 30, 2024
• First Submitted That Met QC Criteria: October 31, 2024
• First Posted (Actual): November 4, 2024

Study Record Updates

• Last Update Posted (Estimated): June 5, 2025
• Last Update Submitted That Met QC Criteria: June 4, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Cardiopulmonary resuscitation; Double defibrillation
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Heart Arrest; Out-of-Hospital Cardiac Arrest; Ventricular Fibrillation
• Other Study ID Numbers: 724951

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The full study protocol, statistical analysis plan, information letter for consent and other trial documents will be published open access. The clinical study report and statistical analysis report will also be made openly available but may be altered to hide information that may lead to identification of individual study participants.
• IPD Sharing Time Frame: Study protocol and ICF will be available before study start. SAP will be available before first interim analysis.

IPD Sharing 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.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No