A Randomized Trial Assessing the Effect of Early Double Sequential Defibrillation With Anterior-posterior and Anterior Lateral Pad Placement and Sequential Defibrillation Compared to Standard Pad Placement and Single Defibrillation in Patients With Out of Hospital Cardiac Arrest With Initial Shockable Rhythm and at Least One Failed Standard Defibrillation

Status: Recruiting
Location: See all (8) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Phase 2/Phase 3
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). If DSD can increase survival among all patients in VF that dont respond to one defibrillation, i.e. before it has become refractory is not known. The aim of this trial is to assess survival with a double defibrillation strategy initiated as soon as possible among patients with Out of Hospital Cardiac Arrest with initial shockable rhythm and at least one failed standard defibrillation, compared with continued resuscitation using standard defibrillation.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• OHCA patients with VT/VF at first rhythm analysis and at least one defibrillation performed in standard (A-L) position

Locations
Other Locations
Sweden
Sjukvården i väster
RECRUITING
Alingsås
Ambulanssjukvården Skaraborgs Sjukhus, Västra Götalandsregionen (SKAS)
NOT_YET_RECRUITING
Borås
Emergency medical services, Södra Älvsborgs Sjukhus, Region Västra Götaland
NOT_YET_RECRUITING
Borås
Prehospital Intensive Care Unit (PIV) AnOPIVA Östra Sjukhuset/SU
RECRUITING
Gothenburg
Shalgrenska University Hospital
RECRUITING
Gothenburg
Ambulanssjukvården, Region Halland
NOT_YET_RECRUITING
Halmstad
Ambulanssjukvården Region Värmland
NOT_YET_RECRUITING
Karlstad
Emergency medical services NU-Sjukvården, Region Västra Götaland
NOT_YET_RECRUITING
Trollhättan
Contact Information
Primary
Gabriel Riva, M.D. Ph.D
gabriel.riva@ki.se
+ 47 70 545 20 86
Backup
Akil Awad, M.D. Ph.D.
akil.awad@ki.se
(+46) 070 400 13 63
Time Frame
Start Date: 2025-09-08
Estimated Completion Date: 2029-12
Participants
Target number of participants: 916
Treatments
Experimental: Early Double sequential defibrillation
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.
Active_comparator: Standard defibrillation
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.
Sponsors
Leads: Gabriel Riva
Collaborators: Region Stockholm, Vastra Gotaland Region, Laerdal Foundation, Swedish Heart Lung Foundation, Region Halland

This content was sourced from clinicaltrials.gov