Early Double Sequential Defibrillation in Out-of-hospital Cardiac Arrest

NCT06447805 | Completed

• 1 other identifier: CIV-ID-24-01-045759
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 3

Brief Summary

Some of the patients affected by Out-of-hospital cardiac arrest (OHCA) with ventricular fibrillation (VF)/ventricular tachycardia (VT) do not respond to initial defibrillation. The survival decreases with number of defibrillations required to terminate VF/VT. In 2022, one prospective cluster randomized trial showed increased survival among (OHCA) patients in refractory VF using Double Sequential Defibrillation (DSD). To evaluate feasibility and safety this randomized pilot trial will compare the effect of double defibrillation strategy initiated as soon as possible after the first defibrillation with continued resuscitation using standard defibrillation, in patients with Out of Hospital Cardiac arrest (OHCA). The results from this pilot trial will form the basis for design of a larger multicenter survival study.

Conditions

Cardiac Arrest; Fibrillation, Ventricular; Sudden Cardiac Death; Sudden Cardiac Arrest

Keywords

Cardiopulmonary resuscitation; Defibrillation; Double sequential defibrillation

Outcome Measures

Primary Outcomes (6)

• Feasibility of early double sequential external defibrillation (DSD)

  Number of EMS defibrillations prior to randomization (target \> 80% before third defibrillation)

  day 1

• Adherence to double sequential external defibrillation (DSD)

  Among patients randomized to DSD, proportion that received DSD (target \> 80%)

  day 1

• Cross-over

  Among patients randomized to standard, proportion that received DSD (target \< 10%)

  day 1

• Feasibility of double sequential external defibrillation (DSD)

  Proportion of eligible patients included and randomized (target \> 80%)

  day 1

• Safety of double sequential external defibrillation

  Major adverse events (e.g. defibrillator malfunction)

  day 1

• Safety of CPR during double sequential external defibrillation

  Chest compression fraction (hands off time during CPR, target \> 80% in both groups)

  day 1

Secondary Outcomes (7)

• Return of spontaneous circulation (ROSC)

  day 1

• Number of defibrillations to sustained ROSC

  day 1

• Survival to hospital admission

  day 1

• Survival to discharge

  day 1-180

• 30 day survival

  day 30

Study Arms (2)

Double Sequential Defibrillation (DSD)

EXPERIMENTAL

If the patient is randomized to the DSD group, the ambulance crew team will apply the second defibrillator with electrodes placed in the A-P position as soon as possible. Defibrillation is performed by one person defibrillating both defibrillators in a sequential manner "Double Sequential Defibrillation" (DSD). All consecutive defibrillations will thereafter be performed with the DSD strategy until ROSC, termination of resuscitation or decision to move the patient to hospital.

Device: Double Sequential Defibrillation (DSD)

Standard defibrillation

ACTIVE COMPARATOR

If the patient is randomized to the standard defibrillation group, the ambulance crew team will continue Advanced life support in accordance with standard of care and continue to perform standard defibibrillation using one defibrillator. All consecutive defibrillations will thereafter be performed with the standard defibrillation strategy until ROSC, termination of resuscitation or decision to move the patient to hospital.

Device: Standard defibrillation

Interventions

Double Sequential Defibrillation (DSD) DEVICE

The second defibrillator will be applyed with electrodes placed in the A-P position

Double Sequential Defibrillation (DSD)

Standard defibrillation DEVICE

Standard defibrillation uning one defibrillator

Standard defibrillation

Eligibility Criteria

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

You may qualify if:

• Out-of-Hospital patients with Ventricular Fibrillation/ Ventricular Tachycardia at rhythm analysis after ambulance arrival and at least one defibrillation performed in standard (Antero-Lateral) position

You may not qualify if:

• Age below 18 years
• Obvious pregnancy
• Known preexisting Do Not Attempt Resuscitation order

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (3)

Emergency medical services Region Halland

Halmstad, Halland County, 30238, Sweden

Location

Sahlgrenska Universitetssjukhuset, Ambulans och Prehospital Akutsjukvård

Gothenburg, Västra Götalandsregionen, 411 04, Sweden

Location

Sjukhusen i väster, ambulanssjukvården Alingsås/Lerum

Alingsås, Västra Götalandsregionen, 441 39, Sweden

Location

Related Publications (1)

• Cheskes S, Verbeek PR, Drennan IR, McLeod SL, Turner L, Pinto R, Feldman M, Davis M, Vaillancourt C, Morrison LJ, Dorian P, Scales DC. Defibrillation Strategies for Refractory Ventricular Fibrillation. N Engl J Med. 2022 Nov 24;387(21):1947-1956. doi: 10.1056/NEJMoa2207304. Epub 2022 Nov 6.

  PMID: 36342151 RESULT

MeSH Terms

Conditions

Heart Arrest; Ventricular Fibrillation; Death, Sudden, Cardiac

Condition Hierarchy (Ancestors)

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

Study Officials

• Gabriel Riva, MD, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

• Akil Awad, MD, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

• Andreas Claesson, RN, PhD

  Karolinska Institutet

  STUDY CHAIR

• Carl Magnusson, RN, PhD

  Sahlgrenska University

  STUDY CHAIR

• Leif Svensson, MD, PhD

  Karolinska Institutet

  STUDY CHAIR

• Johan Israelsson, RN, PhD

  Linné University

  STUDY CHAIR

• Emma Blick-Nordqvist, MD

  Karolinska Institutet

  STUDY CHAIR

• Martin Jonsson, Msc, PhD

  Karolinska Institutet

  STUDY CHAIR

• Jacob Hollenberg, MD, PhD

  Karolinska Institutet

  STUDY CHAIR

• Sheldon Cheskes, MD

  University of Toronto

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, M.D., Ph.D. Center for resuscitation Scinence

Model Details: Academic, investigator initiated, open-label pilot study with a randomized controlled trial (RCT) design and 3:1 allocation (3 intervention: 1 standard).

Study Record Dates

• First Submitted: May 29, 2024
• First Posted: June 7, 2024
• Study Start: August 1, 2024
• Primary Completion: May 31, 2025
• Study Completion: September 23, 2025
• Last Updated: October 1, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

SE (3)