Diaphragm Structure and Pathobiology in Patients Being Bridged to Lung Transplant
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: Respiratory support.
- Кому может быть актуально
- Состояния в реестре: Diaphragm Injury, Respiratory Failure, Mechanical Ventilation Complication. 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
- Канада
- 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 study is designed to characterize the changes in diaphragm structure, function and biology during bridging to lung transplant by mechanical ventilation or extracorporeal life support.
Подробное описание
Mechanical ventilation has been linked to diaphragm injury and dysfunction. During mechanical ventilation, the amount of breathing work done by the diaphragm is unpredictable: the diaphragm could be completely rested, or it could be overworked. Either of these possibilities may cause injury to the diaphragm. Patients with an injured and dysfunctional diaphragm have greater difficulty weaning from mechanical ventilation - they become too weak to breathe. However, little is known about the relationship between changes in the diaphragm and the histological (structure of cells and tissue) basis of these changes. The investigators have developed a new technique employing beside ultrasound to measure diaphragm thickness. This allows them to observe changes in diaphragm muscle structure and function.
The goal of the study is to determine whether different forms of respiratory support (mechanical ventilation vs extracorporeal life support) lead to different degrees of diaphragm injury and to compare changes in the diaphragm seen on ultrasound to changes in the diaphragm tissues under a microscope. This will help the investigators to confirm the best way to avoid diaphragm injury and to understanding the meaning of diaphragm ultrasound images.
Вмешательства
- Устройство Respiratory support
Mechanical ventilation or extracorporeal life support
Первичные конечные точки
- Difference in diaphragm thickness and thickening fraction in patients using MV and patients using ECLS [Срок оценки: Change from baseline diaphragm thickness and thickening fraction at 7 days after lung transplant]
Вторичные конечные точки (2)
- Correlate changes in diaphragm thickness and histological features of diaphragm dysfunction [Срок оценки: Assessed immediately after transplantation]
- Biomarkers for diaphragm dysfunction [Срок оценки: Assessed immediately before transplantation]
Критерии участия
Inclusion Criteria (Cases):
- Receiving a respiratory support modality as a bridge to lung transplantation
- Formally listed for transplantation
Inclusion Criteria (Control Group 1):
\- Undergoing lung transplantation for either obstructive or restrictive lung disease
Inclusion Criteria (Control Group 2):
\- Undergoing elective thoracic surgery without any prior history of chronic pulmonary parenchymal disease
Exclusion Criteria (Cases and Controls):
- Previously diagnosed with neuromuscular disorder
- Received invasive mechanical ventilation for >48 hours in the preceding four weeks
- Thoracic cage deformity
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
Канада · 1 центр
- Toronto General Hospital — Toronto
Идентификаторы
NCT: NCT03667027 · 18-5660