- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT07834970
Mechanical Power During Pressure Controlled Versus Volume-Controlled Ventilation in Acute Respiratory Failure (MP-PCV-VCV)
Mechanical Power During Pressure-Controlled Versus Volume Controlled Mechanical Ventilation in Patients With Acute Respiratory Failure
This prospective observational cohort study aims to compare mechanical power between pressure-controlled ventilation (PCV) and volume-controlled ventilation (VCV) in critically ill adult patients receiving invasive mechanical ventilation. Mechanical power will be assessed at different time points during the first 24 hours after intubation, with the primary comparison performed at 24 hours. The study will also evaluate the association between mechanical power and clinical outcomes, including ICU mortality, hospital mortality, successful weaning, duration of mechanical ventilation, and length of ICU and hospital stay.
Обзор исследования
Статус
Подробное описание
Mechanical ventilation is a life-saving intervention for critically ill patients with acute respiratory failure. However, mechanical ventilation can also contribute to ventilator-induced lung injury when excessive energy is delivered to the respiratory system. Mechanical power, which represents the energy transferred from the ventilator to the respiratory system per unit of time, has emerged as a potentially important parameter for assessing the intensity of mechanical ventilation.
The mode of ventilation may influence mechanical power through changes in airway pressure, tidal volume, respiratory rate, and inspiratory flow. Pressure-controlled ventilation (PCV) and volume-controlled ventilation (VCV) are commonly used modes of invasive mechanical ventilation, but their effects on mechanical power in critically ill patients may differ.
Therefore, this prospective observational cohort study aims to compare mechanical power between PCV and VCV in critically ill adult patients receiving invasive mechanical ventilation and to evaluate the relationship between mechanical power and relevant clinical outcomes.
Тип исследования
Регистрация (Оцененный)
Контакты и местонахождение
Контакты исследования
- Имя: Sahar Ahmed Okily, Master degree of chest disease
- Номер телефона: 01094504484 0201094504484
- Электронная почта: sara3hmed2012@gmail.com
Учебное резервное копирование контактов
- Имя: Hend Mohamed Sayed, Lecturer
- Номер телефона: 0201098988712
- Электронная почта: Hendmohamed@aun.edu.eg
Места учебы
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Asyut, Египет
- Assuit university
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Метод выборки
Исследуемая популяция
Adult patients aged >18 years with acute respiratory failure requiring invasive mechanical ventilation and admitted to the Respiratory Intensive Care Unit at Assiut University Hospitals will be enrolled. Eligible patients receiving either pressure-controlled ventilation (PCV) or volume-controlled ventilation (VCV) will be prospectively followed during their ICU and hospital stay.
Описание
Inclusion Criteria:
- Adult patients aged >18 years.
- Patients with acute respiratory failure who are receiving invasive mechanical ventilation.
Exclusion Criteria:
- Patients whose condition requires shifting between VCV and PCV after enrollment.
- Patients with neurological, neuromuscular, or muscular disorders.
- Neurological disorders, e.g., stroke, multiple sclerosis, Parkinsonism, and Guillain-Barré syndrome.
- Neuromuscular junction disorders, e.g., myasthenia gravis.
- Muscular disorders, e.g., polymyositis and Duchenne muscular dystrophy.
- Chest wall abnormalities, e.g., kyphoscoliosis, scoliosis, and pectus excavatum.
- Tracheostomized patients.
- Patients with raised intra-abdominal pressure (IAP ≥12 mmHg), as estimated by transvesical manometry e.g., massive ascites, bowel obstruction, and postoperative abdominal surgery.
- Patients with documented chronic type 2 respiratory failure, characterized by an elevated partial pressure of carbon dioxide (PaCO₂ >45 mmHg), low partial pressure of oxygen (PaO₂), and chronically elevated bicarbonate (HCO₃-) reflecting renal compensation.
Учебный план
Как устроено исследование?
Детали дизайна
- Наблюдательные модели: COHORT
- Временные перспективы: PROSPECTIVE
Когорты и вмешательства
Группа / когорта |
|---|
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93 patients in Pressure controlled ventilation
93 patients in Volume controlled ventilation |
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93 patients in PCV
93 patients in Volume controlled ventilation |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Mechanical power
Временное ограничение: 24 hours after intubation
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Mechanical power will be measured and compared between pressure-controlled ventilation (PCV) and volume-controlled ventilation (VCV) at 24 hours after intubation. |
24 hours after intubation
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
mechanical power and ICU mortality, hospital mortality, time to death.
Временное ограничение: From hospital admission until 30 days after hospital admission.
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Correlation between mechanical power and ICU mortality, hospital mortality, time to death .
|
From hospital admission until 30 days after hospital admission.
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Mechanical power over time
Временное ограничение: At 1, 6, 12, and 24 hours after initiation of invasive mechanical ventilation.
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Changes in mechanical power over time following initiation of invasive mechanical ventilation. |
At 1, 6, 12, and 24 hours after initiation of invasive mechanical ventilation.
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Successful weaning from mechanical ventilation
Временное ограничение: From intubation until successful weaning( successful extubation without need for ventilatory support within the following 48 hours)
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Correlation between Mechanical power and successful weaning from mechanical ventilation .Successful weaning is defined as successful extubation without the need for re-intubation or noninvasive ventilation (NIV) within the following 48 hours. |
From intubation until successful weaning( successful extubation without need for ventilatory support within the following 48 hours)
|
Соавторы и исследователи
Спонсор
Следователи
- Директор по исследованиям: Olfat Mostafa El shinawy, Professor, Assiut University, Faculty of Medicine, Chest Diseases Department, Assiut, Egypt
- Директор по исследованиям: Sara Mohamed Hashem, Lecteurer, Assiut University, Faculty of Medicine, Chest Diseases Department, Assiut, Egypt
Публикации и полезные ссылки
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Другие идентификационные номера исследования
- AUN-CH-MP-001
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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