Clinical trial NCT06672159: Initial Double Sequential External Defibrillation in Out of Hospital Cardiac Arrest
Official title: A Randomized Controlled Trial on Early Double External Sequential Defibrillation in Out of Hospital Cardiac Arrest
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cardiac Arrest
Out-Of-Hospital Cardiac Arrest
Ventricular Fibrillation
Keywords: Double defibrillation
Cardiopulmonary resuscitation
Lead sponsor: St. Olavs Hospital
Sponsor class: OTHER
Collaborators: name: Norwegian Air Ambulance Foundation
First posted: 2024-11-04
Enrollment: 356
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: All included ambulance stations will perform one of the two procedures for six months followed by a crossover for six months.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: The project is investigator-initiated, prospective, two-group randomized controlled trial (RCT). Prior to the RCT, a pilot feasibility trial of 3-4 months will be performed, including three ambulance bases in mid-Norway. All OHCA patients will be included until validity and feasibility of the study is accomplished. The pilot study will be followed by the RCT.

Outcome measurements in the RCT are aimed to be the same as in the pilot study. Ambulance bases will be randomized to either DSED or standard procedure for six months before crossover with the other treatment for six months.

Ambulances included in the project will carry two defibrillators. Both defibrillators will be established for initial defibrillation with DSED in OHCA patients. The pads are placed in anterior-lateral position (standard placement) and anterior-posterior position (over sternum and beneath left scapula). Shocks are administered in rapid succession with less than one second apart. All other treatment will be according to existing guidelines.

The included patients are OHCA patients with age over 18 years presenting with a shockable rhythm. Excluded patients are patients with obvious or suspected pregnancy, incarcerated patients or patients with no-resuscitation order. The patients that meet the inclusion criteria will be registered by the ambulance personnel through a secure webpage.

Primary outcome is survival to hospital admission.

Secondary outcomes are survival to hospital discharge, 30 days, 90 days and 1 year survival, in addition to neurological status.

Patients from the pilot will be included in the RCT intervention group.

Eligibility 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

Primary outcomes:
measure: Proportion of patients that survive to hospital admission.
timeFrame: 24 hours
Secondary outcomes:
measure: Proportion of patients that survive for 30 days
timeFrame: 30 days
measure: Review of 30 day neurological status.
timeFrame: 30 days
measure: Proportion of patients that survive for 90 days
timeFrame: 90 days
measure: Review 90 day neurological status.
timeFrame: 90 days
measure: Proportion of patients that survive for one year.
timeFrame: 365 days
Other outcomes:
measure: Incidence of patient-related adverse effects.
timeFrame: 365 days
measure: Incidence of malfunction of defibrillator.
timeFrame: 365 days
Locations:
city: Trondheim
country: Norway
facility: St Olavs Hospital
Study officials:
affiliation: St. Olavs Hospital
name: Kjetil Karlsen
role: STUDY_DIRECTOR
References: