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Идёт набор NCT07041086

Prehospital ECPR in Moravia Silesia Region

Наблюдательное Cardiac Arrest, Out-Of-Hospital

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: Extracorporeal membrane oxygenation (ECMO).
Кому может быть актуально
Состояния в реестре: Cardiac Arrest, Out-Of-Hospital. Базовые параметры: 18 лет — 70 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
Чехия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Prehospital ECPR in Moravia Silesia Region - Assessing the Effectiveness, Feasibility and Time of ECPR by Simulating Connections and Real Interventions.

Обзор

Cardiopulmonary resuscitation (CPR) for out-of-hospital cardiac arrest (OHCA) in specific cases could be improved by Extracorporeal membrane oxygenation (ECMO; ECPR). ECPR could be introduced in hospital after retrieval of an OHCA patient and also faster by implantation on scene. The aim is to verify the effectiveness of ECPR on scene in the Moravian-Silesian region.

Подробное описание

Patients undergoing cardiopulmonary resuscitation (CPR) for out-of-hospital cardiac arrest (OHCA) have a poor prognosis and a good long-term neurological outcome is achieved in about 10% of them. Extracorporeal membrane oxygenation (ECMO) can lead to an improvement in neurological outcome of up to 30% in a selected group of these critically ill patients. CPR for OHCA using ECMO in the hospital after patient admission (ECPR) is very demanding and depends on the best collaboration of pre-hospital care components with the hospital management. As good as the coordination of the different phases of care and transport is, patients often arrive to the hospital relatively late (over 60 minutes), and although the process of diagnosis and indication and ECMO implantation itself is rapid (approximately 15 minutes), the overall time from collapse to ECMO initiation is relatively long (over 60 minutes). It is this time, i.e. the duration of low organ perfusion during CPR, that may be the key parameter in determining the overall neurological outcome of treatment and prognosis of patients. Shortening this interval by having the ECMO team go to well-defined OHCA cases simultaneously with the ambulance car of the Emergency Department and connecting the patient to ECMO already in the field may lead to an improvement in the neurological outcome of the treatment of OHCA patients. In many locations abroad, this model is already used, and patients are connected to ECMO already in the field. Whether the model of field ECPR can be used in the Moravian-Silesian Region depends on a number of variables. These include the logic of information acquisition and selection of suitable patients, the logic of transporting the team and material to the scene, and the logic of connection with the provision of a safe and suitable environment for the ECMO implantation itself. The goal of this study is to validate the feasibility of the method on a simulated ECPR OHCA and further implant the mobile ECPR project in the Moravian-Silesian region.

Вмешательства

  • Процедура Extracorporeal membrane oxygenation (ECMO)
    In extracorporeal membrane oxygenation (ECMO), blood is pumped outside of the body to a heart-lung machine. The machine removes carbon dioxide and sends oxygen-rich blood back to the body. Blood flows from the right side of the heart to the heart-lung machine. It's then rewarmed and sent back to the body.

Первичные конечные точки

  • Time from cardiac arrest (collapse) to implantation of ECMO [Срок оценки: up to 60 minutes]
  • Hospital mortality [Срок оценки: up to 3 weeks]
  • Cerebral Performance Category (CPC) score [Срок оценки: 30 days]
  • Neurological outcome (CPC score) [Срок оценки: 6 months]
  • Neurological outcome (SF-36) [Срок оценки: 6 months]
  • Neurological outcome (EQ-5D) [Срок оценки: 6 months]

Критерии участия

Критерии включения

  • Age ≥ 18 years
  • Observed collapse and presumption of cardiac cause of cardiac arrest
  • Estimated age up to 70 years
  • Baseline rhythm of ventricular fibrillation or pulseless electrical activity (PEA)
  • Basic bystander cardiopulmonary resuscitation (CPR), "bystander CPR", telephone assisted CPR (TANR)

Критерии исключения

  • Children or adults with estimated weight below 40 kg
  • Known major comorbidities of the patient suggesting low rehabilitation potential (e.g. chronic obstructive pulmonary disease (COPD) IV, malignancy in tertiary phase)

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Только случаи

Центры проведения

Чехия · 2 центра
  • Emergency Medical Services, Moravian-Silesian Region — Ostrava
  • University Hospital Ostrava — Ostrava

Идентификаторы

NCT: NCT07041086 · FNO-KARIM-01-Pain

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗