Идёт набор NCT04754854

Reduction of Blood Recirculation in Veno-Venous ECMO

— Наблюдательное Extracorporeal Membrane Oxygenation Acute Respiratory Distress Syndrome

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: Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально: Состояния в реестре: Extracorporeal Membrane Oxygenation, Acute Respiratory Distress Syndrome. 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 →

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Официальное название

Reduction of Blood Recirculation in Veno-Venous ECMO Through Ultrasound Dilution Measurements (ECMO Circulation Study)

Обзор

Blood which recirculates through the circuit of a veno-venous Extracorporeal Membrane Oxygenation (V-V ECMO) does not contribute to the systemic oxygenation of a patient on V-V ECMO and is called the recirculation fraction (Rf). Theoretically, the optimization of ECMO blood flow is possible using Rf measurements. A prospective, observational study will be performed measuring the Rf of total ECMO blood flow in patients with acute respiratory distress syndrome (ARDS) on V-V ECMO with an ultrasound dilution technique. ECMO blood flow will be optimized by reducing ECMO blood flow in accordance with the measured Rf as long as systemic oxygenation is not compromised.

Подробное описание

Based on data from the 'Blood Recirculation and vvECMO' trial (ClinicalTrials.gov ID: NCT03200314) (i.e. an expected frequency of successful blood flow reduction of 66.7%), using a one-sample Chi square test, a two-sided type-1 error of 5%, a power of 80%, a total of 68 patients is needed to show that the proportion of patients with a secure ECMO blood flow reduction is greater than 50%. Presumably, 136 Patients have to be included into the trial to study 68 patients with a relevant Rf since not all patients on V-V ECMO suffer from a high Rf.

Первичные конечные точки

Successful ECMO blood flow reduction [Срок оценки: Once within the first week after initiation of ECMO therapy]

Вторичные конечные точки (12)

Recirculation fraction [Срок оценки: Once within the first week after initiation of ECMO therapy]
Arterial blood oxygen content [Срок оценки: Once within the first week after initiation of ECMO therapy]
Extracorporeal blood Flow [Срок оценки: Once within the first week after initiation of ECMO therapy]
Extracorporeal gas flow [Срок оценки: Once within the first week after initiation of ECMO therapy]
Length of ECMO therapy [Срок оценки: Daily until the end of ECMO therapy (approximately 14 days)]
Cannula position and distance [Срок оценки: Once within the first week after initiation of ECMO therapy]
Right heart dysfunction [Срок оценки: Once within the first week after initiation of ECMO therapy]
Length of mechanical ventilation [Срок оценки: Entire duration of the ICU stay (approximately 28 days)]
Complications of ECMO therapy [Срок оценки: Length of ECMO therapy (approximately 14 days)]
ICU mortality [Срок оценки: Entire duration of the ICU stay (approximately 28 days)]
ICU length of stay [Срок оценки: Entire duration of the ICU stay (approximately 28 days)]
Incidence of ICU-acquired organ dysfunctions and complications [Срок оценки: Entire duration of the ICU stay (approximately 28 days)]