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Идёт набор NCT06672159

Initial Double Sequential External Defibrillation in Out of Hospital Cardiac Arrest

Без фазы С лечением Cardiac Arrest Out-Of-Hospital Cardiac Arrest Ventricular Fibrillation

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Two defibrillators, One defibrillator.
Кому может быть актуально
Состояния в реестре: Cardiac Arrest, Out-Of-Hospital Cardiac Arrest, Ventricular Fibrillation. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Норвегия
Следующий шаг
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Официальное название

A Randomized Controlled Trial on Early Double External Sequential Defibrillation in Out of Hospital Cardiac Arrest

Обзор

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.

Подробное описание

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.

Вмешательства

  • Устройство Two 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.
  • Устройство One defibrillator
    Standard OHCA treatment according to existing guidelines.

Первичные конечные точки

  • Proportion of patients that survive to hospital admission. [Срок оценки: 24 hours]
Вторичные конечные точки (5)
  • Proportion of patients that survive for 30 days [Срок оценки: 30 days]
  • Review of 30 day neurological status. [Срок оценки: 30 days]
  • Proportion of patients that survive for 90 days [Срок оценки: 90 days]
  • Review 90 day neurological status. [Срок оценки: 90 days]
  • Proportion of patients that survive for one year. [Срок оценки: 365 days]

Критерии участия

Критерии включения

  • Patients with out of hospital cardiac arrest presenting with a shockable rhythm

Критерии исключения

  • Age below 18 years
  • Obvious or suspected pregnancy
  • Incarcerated patients
  • Preexisting do-not-resuscitate order

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Перекрёстный дизайн
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Норвегия · 1 центр
  • St Olavs Hospital — Trondheim

Публикации

  • Cheskes S, Drennan IR, Turner L, Pandit SV, Walker RG, Dorian P. The impact of alternate defibrillation strategies on time in ventricular fibrillation. Resuscitation. 2025 Apr;209:110549. doi: 10.1016/j.resuscitation.2025.110549. Epub 2025 Feb 17. PMID 39970979

Идентификаторы

NCT: NCT06672159 · 724951

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗