The trial
The overall aim of this pilot study is to evaluate the feasibility of a randomized controlled trial comparing a strategy of early double sequential defibrillation (DSD) with standard defibrillation in patients with cardiac arrest who remain in VT/VF after the first defibrillation.
DoubleD is a Swedish, academically initiated and designed randomized pilot study. The study is being conducted by the Center for Cardiac Arrest Research at Karolinska Institute. The study is prospective, 3:1 randomized (3 DSD: 1 standard), and will continue until 40 patients have been included. Patients are randomized by specially trained ambulance personnel at the location of the cardiac arrest to either DSD treatment (intervention) or standard defibrillation (control).
The pilot study is being conducted within the ambulance services in Alingsås, Kungälv, and Sahlgrenska University Hospital. If the results are positive, the goal is to proceed with a larger main study evaluating survival.
Inclusioncriteria
- Out-of-hospital cardiac arrest where at least one defibrillation has been performed (it does not matter who performed the first defibrillation(s)).
- There must be 2 defibrillators approved for double defibrillation available on-site. As of now (October 2024), these are only Corpuls3 + Corpuls3 that are allowed.
Exclusioncriteria
- Age below 18 years
- Patients with known or appearent pregnancy
- Previous decision to not resuscitate
Outcome is defined as feasibility and safety according to the following;
FEASIBILITY
– The number of defibrillations by the ambulance before randomization (target >80% before the third defibrillation).
– Among patients randomized to DSD, the proportion who received DSD (target >80%).
– Among patients randomized to standard, the proportion who received DSD (target <10%).
– The proportion of patients who met the inclusion criteria and were included and randomized (target >80%).
SAFETY
- Serious adverse effects (such as defibrillator failure)
– Interruptions in chest compressions during CPR (defined as the proportion of time during CPR when chest compressions are being performed; target >80% in both groups)
– Neurological function and health-related quality of life at 90 and 180 days
For detailed information, secondary and tertiary outcomes, as well as methodology, see CIP or CIP-summary.
If we can demonstrate in this pilot study that early DSD treatment is feasible and safe, then we plan to move on with a main study, which will include significantly more EMS and patients. ambulanssystem och patienter.