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Initial Double Sequential External Defibrillation in Out of Hospital Cardiac Arrest

ConditionsCardiac ArrestOut-Of-Hospital Cardiac ArrestVentricular Fibrillation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSt. Olavs Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with out of hospital cardiac arrest presenting with a shockable rhythm

Disqualifiers

Age below 18 years

Obvious or suspected pregnancy

Incarcerated patients

Preexisting do-not-resuscitate order

Trial design

Design model

Crossover

Treatments tested in this trial

  • Two defibrillators

    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.

  • One defibrillator

    Device

    Standard OHCA treatment according to existing guidelines.

Treatment groups

356 Participants
are divided into 2 treatment groups
Group A: Double sequential external defibrillationExperimental treatment 1 intervention
Group B: Standard treatmentActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Proportion of patients that survive to hospital admission.

Number of patients arriving with ROSC in hospital emergency facility.

Time frame
24 hours

Secondary outcomes

1

Proportion of patients that survive for 30 days

Number of patients that have survived OHCA incident after 30 days.

Time frame
30 days
2

Review of 30 day neurological status.

Modified Rankin Scale (1 No significant disability - 5 Severe disability) defines neurological outcome of OHCA.

Time frame
30 days
3

Proportion of patients that survive for 90 days

Number of patients that have survived OHCA incident after 90 days.

Time frame
90 days
4

Review 90 day neurological status.

Modified Rankin Scale (1 No significant disability - 5 Severe disability) defines neurological outcome of OHCA.

Time frame
90 days

Other outcomes

1

Incidence of patient-related adverse effects.

Measure/obtain information regarding adverse effects experience by patient using DSED procedure.

Time frame
365 days
2

Incidence of malfunction of defibrillator.

Assess information regarding occurrence of defibrillator damage after DSED procedure.

Time frame
365 days

Sponsors and contacts

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

St. Olavs Hospital

Lead sponsor

Norwegian Air Ambulance Foundation

Collaborator

Source ClinicalTrials.gov
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