Cardiac Arrest, Out-Of-Hospital Cardiac Arrest, Ventricular Fibrillation
Conditions
Keywords
Double defibrillation, Cardiopulmonary resuscitation
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.
Interventions
DEVICETwo defibrillators
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.
DEVICEOne defibrillator
Standard OHCA treatment according to existing guidelines.
Sponsors
St. Olavs Hospital
Norwegian Air Ambulance Foundation
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
All included ambulance stations will perform one of the two procedures for six months followed by a crossover for six months.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients that survive to hospital admission. | 24 hours | Number of patients arriving with ROSC in hospital emergency facility. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients that survive for 30 days | 30 days | Number of patients that have survived OHCA incident after 30 days. |
| Review of 30 day neurological status. | 30 days | Modified Rankin Scale (1 No significant disability - 5 Severe disability) defines neurological outcome of OHCA. |
| Proportion of patients that survive for 90 days | 90 days | Number of patients that have survived OHCA incident after 90 days. |
| Review 90 day neurological status. | 90 days | Modified Rankin Scale (1 No significant disability - 5 Severe disability) defines neurological outcome of OHCA. |
| Proportion of patients that survive for one year. | 365 days | Number of patients that have survived OHCA incident after 365 days. |
Countries
Norway
Contacts
CONTACTJostein R Brede, MD
CONTACTVegard Nordviste, MD, PhD
STUDY_DIRECTORKjetil Karlsen
St. Olavs Hospital
Outcome results
None listed