Cardiac Arrest Clinical Trial
— DOUBLE-DOfficial title:
"A Pilot Study Assessing Feasibility of a Randomized Trial Comparing the Effect of Early Double Sequential Defibrillation as Soon as Possible in OHCA With a Shockable Rhythm (VT/VF) Compared to Standard Defibrillation"
Some of the patients affected by Out-of-hospital cardiac arrest (OHCA) with ventricular fibrillation (VF)/ventricular tachycardia (VT) do not respond to initial defibrillation. The survival decreases with number of defibrillations required to terminate VF/VT. In 2022, one prospective cluster randomized trial showed increased survival among (OHCA) patients in refractory VF using Double Sequential Defibrillation (DSD). To evaluate feasibility and safety this randomized pilot trial will compare the effect of double defibrillation strategy initiated as soon as possible after the first defibrillation with continued resuscitation using standard defibrillation, in patients with Out of Hospital Cardiac arrest (OHCA). The results from this pilot trial will form the basis for design of a larger multicenter survival study.
Status | Not yet recruiting |
Enrollment | 40 |
Est. completion date | June 1, 2026 |
Est. primary completion date | December 31, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Out-of-Hospital patients with Ventricular Fibrillation/ Ventricular Tachycardia at rhythm analysis after ambulance arrival and at least one defibrillation performed in standard (Antero-Lateral) position Exclusion Criteria: - Age below 18 years - Obvious pregnancy - Known preexisting Do Not Attempt Resuscitation order |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Karolinska Institutet |
Cheskes S, Verbeek PR, Drennan IR, McLeod SL, Turner L, Pinto R, Feldman M, Davis M, Vaillancourt C, Morrison LJ, Dorian P, Scales DC. Defibrillation Strategies for Refractory Ventricular Fibrillation. N Engl J Med. 2022 Nov 24;387(21):1947-1956. doi: 10. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Feasibility of early double sequential external defibrillation (DSD) | Number of EMS defibrillations prior to randomization (target > 80% before third defibrillation) | day 1 | |
Primary | Adherence to double sequential external defibrillation (DSD) | Among patients randomized to DSD, proportion that received DSD (target > 80%) | day 1 | |
Primary | Cross-over | Among patients randomized to standard, proportion that received DSD (target < 10%) | day 1 | |
Primary | Feasibility of double sequential external defibrillation (DSD) | Proportion of eligible patients included and randomized (target > 80%) | day 1 | |
Primary | Safety of double sequential external defibrillation | Major adverse events (e.g. defibrillator malfunction) | day 1 | |
Primary | Safety of CPR during double sequential external defibrillation | Chest compression fraction (hands off time during CPR, target > 80% in both groups) | day 1 | |
Secondary | Return of spontaneous circulation (ROSC) | Proportion of patients with sustained return of spontaneous circulation (ROSC) at hospital arrival | day 1 | |
Secondary | Number of defibrillations to sustained ROSC | Total number of defibrillations to sustained ROSC | day 1 | |
Secondary | Survival to hospital admission | Pateint is admitted to hospital alive | day 1 | |
Secondary | Survival to discharge | Survival to hospital discharge | day 1-180 | |
Secondary | 30 day survival | Survival at 30 days | day 30 | |
Secondary | Neurological function at 30 days | Neurological function (modified Rankin Scale, mRS 1-6, and Cerebral Performance Category, CPC 1-5) at 30 days | day 30 | |
Secondary | Neurological function and Health related Quality of life at 90 and 180 days | Neurological function (modifiied Rankin Scale and Cerebral Performance Category) and Health-related Quality of life at 90 and 180 days (CPC 1-5, mRS 1-6) | day 90 and 180 |
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