Initial double sequential defibrillation for out-of-hospital ventricular fibrillation
A Randomized Controlled Trial on Early Double External Sequential Defibrillation in Out of Hospital Cardiac Arrest
NA · St. Olavs Hospital · NCT06672159
This trial will test whether using two defibrillators to give double sequential shocks first improves survival for adults with out-of-hospital cardiac arrest and a shockable rhythm.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 356 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | St. Olavs Hospital (other) |
| Locations | 1 site (Trondheim) |
| Trial ID | NCT06672159 on ClinicalTrials.gov |
What this trial studies
This investigator-initiated project begins with a short pilot feasibility phase and proceeds to a two-group randomized, cluster-crossover trial where ambulance bases are randomized to either initial double sequential external defibrillation (DSED) or standard single-defibrillator care for six months and then cross over. Ambulances carry two defibrillators and apply pads in anterior-lateral and anterior-posterior positions, delivering shocks in rapid succession (<1 second apart) for the DSED arm, while all other care follows current guidelines. Eligible participants are adults with out-of-hospital cardiac arrest presenting with a shockable rhythm; exclusions include age <18, suspected pregnancy, incarceration, or a do-not-resuscitate order. The primary outcome is survival to hospital admission, with secondary outcomes including survival to hospital discharge and longer-term survival and neurological status at 30 and 90 days.
Who should consider this trial
Good fit: Adults (≥18 years) who experience out-of-hospital cardiac arrest with a shockable rhythm and who are not pregnant, incarcerated, or subject to a do-not-resuscitate order are ideal candidates.
Not a fit: Patients without a shockable rhythm, children, those with existing do-not-resuscitate orders, suspected pregnancy, or who are incarcerated are not eligible and would not be expected to benefit from this trial intervention.
Why it matters
Potential benefit: If successful, starting treatment with DSED could increase survival to hospital admission and improve longer-term neurological outcomes after out-of-hospital cardiac arrest.
How similar studies have performed: A 2022 clinical trial reported higher survival when DSED was used after failed standard shocks, indicating prior evidence of benefit, but using DSED as the initial treatment is a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Trondheim
- St Olavs Hospital — Trondheim, Norway (RECRUITING)
Study contacts
- Study coordinator: Jostein R Brede, MD
- Email: jostein.brede@norskluftambulanse.no
- Phone: +47 99445914
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cardiac Arrest, Out-Of-Hospital Cardiac Arrest, Ventricular Fibrillation, Double defibrillation, Cardiopulmonary resuscitation