Safety and Performance of the Novalung Ultimate Kit and Xenios 2.0 During Stationary Use in Hospital and Ground-based Transport of Patients on Extracorporeal Life Support (ECLS)
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: Novalung ultimate kit, Xenios 2.0, and MultiSupport Ground (MSG).
- Кому может быть актуально
- Состояния в реестре: Cardio-Respiratory Failure, Extracorporeal Membrane Oxygenation Complication, Acute Lung Injury. 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
- Германия
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Не всё понятно в терминах? Прочитайте наш гид для пациентов →
Обзор
This prospective observational study will evaluate the safety and performance of the Novalung ultimate kit in combination with the Xenios 2.0 and the MultiSupport Ground during stationary use in hospital and ground-based transport of patients treated on extracorporeal membrane oxygenation (ECMO). The primary objective is to assess whether the use of the medical devices improves and maintains the gas exchange (blood oxygenation) in these patients. Medical Devices will be used according to their intended purpose and local standards/ requirements.
Вмешательства
- Устройство Novalung ultimate kit, Xenios 2.0, and MultiSupport Ground (MSG)
Patients will receive ECLS treatment using the Novalung ultimate kit, Xenios 2.0, and MultiSupport Ground (MSG) during ground-based inter-hospital patient transport and/ or stationary treatment according to their intended use and local standards/ requirements.
Первичные конечные точки
- Arterial oxygen saturation (SaO2) [%] [Срок оценки: Baseline and during the ECMO treatment every 24 hours until a maximum of 29 days]
Вторичные конечные точки (5)
- Performance objective Cardiacirculation [Срок оценки: Baseline and during the ECMO treatment every 24 hours until a maximum of 29 days]
- Performance objective Maintenance of blood flow [Срок оценки: Baseline and during the ECMO treatment every 24 hours until a maximum of 29 days]
- Performance objective Pump speed [Срок оценки: Baseline and during the ECMO treatment every 24 hours until a maximum of 29 days]
- Performance objective Circuit pressures [Срок оценки: Baseline and during the ECMO treatment every 24 hours until a maximum of 29 days]
- Safety objectives [Срок оценки: Baseline and during the ECMO treatment every 24 hours until a maximum of 29 days]
Критерии участия
Критерии включения
- Adult patients receiving an ECMO treatment with the Novalung ultimate kit in combination with the Xenios 2.0 (and the MultiSupport Ground during inter- and intra-hospital transport, if applicable) according to the intended use
- Informed consent signed and dated by the attending physician; and
- If patient is able to give consent: by the study patient
- If patient is unable to give consent: by the legal representative or
- If an emergency situation is determined: by a consultant physician
Критерии исключения
- Participation in any interventional clinical study that could impact the results of this prospective, observational PMCF study
- Previous participation in the same study
- ECMO cannulation outside the referring or trial site hospital
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Другое
Центры проведения
Германия · 2 центра
- University Hospital Aachen — Aachen
- Krankenhaus Bethanien gGmbH — Solingen
Идентификаторы
NCT: NCT07156669 · HL-ECMO-01-INT