Early Double Sequential Defibrillation in Out of Hospital Cardiac Arrest

Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorGabriel Riva

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Age < 18 years

Obvious pregnancy

Known preexisting Do Not Attempt Resuscitation order

Trial design

Design model

Parallel

Treatments tested in this trial

  • Double sequential defibirllation

    Device

    A second defibrillator will be applyed with electrodes placed in the A-P position and defibrillation will be performed with two defibrllators in a sequential manner

  • Standard defibrillation

    Device

    Standard defibrillation uning one defibrillator

Treatment groups

916 Participants
are divided into 2 treatment groups
Group A: Early Double sequential defibrillationExperimental treatment 1 intervention
Group B: Standard defibrillationActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

30 day survival

Survival at 30 days

Time frame
30 days

Secondary outcomes

1

ROSC

Any prehospital ROSC, defined as confirmed ROSC by EMS personnel, in accordance with latest Utstein definition

Time frame
1 day
2

Survival to hospital Admission

Admitted alive to a hospital ward with spontaneous circulation

Time frame
1 day
3

Survival to hospital discharge

Discharged alive from hospital

Time frame
30 days
4

Neurological function at hospital discharge, mRS (modified Ranking scale, 1-6 where 1 indicates better function)

Neurological function at hospital discharge (mRS)

Time frame
30 days

Other outcomes

1

90 days survival

Survival to 90 days

Time frame
90 days
2

Neurological function at 90 days (mRS)

Neurological function at 90 days (modified Ranking scale)

Time frame
90 days
3

Helath related quality of life at 90 days

Helath related quality of life at 90 days

Time frame
90 days
4

Neurological function at 180 days (mRS)

Neurological function (modified Ranking Scale)

Time frame
180 days

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Gabriel Riva

Lead sponsor

Karolinska Institutet

Sponsor institution

Swedish Heart Lung Foundation

Collaborator

Region Stockholm

Collaborator

Vastra Gotaland Region

Collaborator

Region Halland

Collaborator

Laerdal Foundation

Collaborator