Establishing Mechanical Thrombectomy at a Limited-volume Stroke Center - Effects on Patient Morbidity and Mortality
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: Simulation based quality program.
- Кому может быть актуально
- Состояния в реестре: Stroke, Acute Ischemic. Базовые параметры: 18 лет — 100 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
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Establishing Mechanical Thrombectomy at a Limited-volume Stroke Center - Effects on Patient Morbidity and Mortality.
Обзор
The regional health authorities of South-East Norway has commissioned Sørlandet Hospital (SSHF), Norway to establish mechanical thrombectomy in large-vessel occlusion stroke. SSHF is a limited volume stroke center, and introduction of thrombectomy may impose quality challenges. Therefore the implementation will be guided by a simulation based quality assurance program. In this study, we will monitor timelines, technical and clinical outcomes, including adverse events.
Подробное описание
In acute stroke, two million neurons are lost per minute. Thrombectomy is the treatment of choice for large vessel occlusion stroke: Each minute saved from stroke onset to successful thrombectomy on average extends the healthy life of young patients by a week. Also, more patients may have a thrombectomy option with early treatment, as the time window for thrombectomy is limited.
In 2019, Sørlandet Hospital Kristiansand (SSK) established thrombectomy for stroke. This spared SSK patients from an over 300 km transport to the comprehensive thrombectomy center in Oslo. Avoiding delays due to long transports may lead to lower morbidity and mortality.
However, SSK is a non-university hospital with a limited patient volume, which may contribute to inferior results. To compensate for this, the implementation of thrombectomy at SSK is guided by a national quality program, which includes systematic skill training, simulation team training and continuous local guideline updates.
The primary objective of this observational study is to find out if implementation of thrombectomy at SSK, guided by the quality program, reduces patient morbidity and mortality.
Long transfer times from smaller hospitals to comprehensive thrombectomy centers pose a major problem for the global stroke community. Thus, our results could be generalizable.
Main aim:
• To determine potential changes in patient morbidity and mortality after introduction of thrombectomy at SSK
Secondary aims:
* To describe associated time periods based on stroke onset, hospital arrival, thrombectomy start, end of procedure * To document technical outcomes of mechanical thrombectomies performed at SSK, i.e. degree of reperfusion after thrombectomy * To document complication rates during mechanical thrombectomies performed at SSK * To describe the implementation of the quality program at SSK * To document performance of simulator skill training over time
Вмешательства
- Другое Simulation based quality program
Stroke team simulation. Virtual reality task training simulation.
Первичные конечные точки
- Mortality [Срок оценки: 3 months]
- Morbidity [Срок оценки: 3 months]
- Symptomatic intracranial hemorrhage [Срок оценки: Within 24 hours of treatment]
Вторичные конечные точки (3)
- Time frames [Срок оценки: Up to 24 hours]
- Technical outcome [Срок оценки: Up to 24 hours]
- Simulation skills [Срок оценки: Up to 5 years]
Критерии участия
Критерии включения
- Adult patients
- Large vessel occlusion stroke
Критерии исключения
- Intracranial hemorrhage, tumor, aneurism or vascular malformation i the stroke area
- More than 24 hours after stroke onset
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Случай-контроль
Центры проведения
Норвегия · 1 центр
- Sørlandet Hospital Health Trust — Kristiansand
Идентификаторы
NCT: NCT04942041 · 66489 (REK)