- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT07559669
Study on the Measurement Method of the Left Diaphragm (LD)
To Study the Consistency of Multiple Measurement Methods of Left Diaphragm Mobility in Critically Ill Patients
Обзор исследования
Статус
Условия
Тип исследования
Регистрация (Оцененный)
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Метод выборки
Исследуемая популяция
Описание
Inclusion Criteria:
①Adult patients (≥18 years old) of both sexes;
In invasive group, intubation or tracheotomy was changed to 5L/min T-tube or tracheotomy mask oxygen inhalation;
Patients in non-invasive group were treated with mask oxygen 5L/min;
- agree to participate in the trial and sign the informed consent;
Exclusion Criteria:
①The diaphragm ultrasound operation site was too large to obtain images.
Diaphragmatic ultrasound images could not be obtained in any section;
The ultrasound image quality of any section was poor;
- the presence of phrenic nerve injury/paralysis ⑤ pregnant women; ⑥ Neuromuscular diseases such as ALS and myasthenia gravis affect the evaluation of spontaneous breathing ⑦ Patients deemed by the investigator to be ineligible.
Учебный план
Как устроено исследование?
Детали дизайна
Когорты и вмешательства
Группа / когорта |
|---|
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Invasive respiratory support group
The subjects of ultrasound measurement were patients with invasive mechanical ventilation
|
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Noninvasive respiratory support group
The subjects of ultrasound measurement were patients with non-invasive respiratory support
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Consistency of diaphragmatic mobility measurements between the standard and modified positions on the left side.
Временное ограничение: Measurements were performed 5 minutes after all patients were switched to conventional oxygen therapy at 5 L/min for the first time, once breathing had stabilized.
|
The main purpose is to verify the consistency of the two methods, Measurements were performed after switching patients in the invasive group (intubated patients to T-piece oxygen at 5 L/min and tracheostomized patients to face mask oxygen at 5 L/min following weaning), and patients in the non-invasive group (those receiving non-invasive ventilation or high-flow oxygen therapy) to conventional face mask oxygen at 5 L/min.
|
Measurements were performed 5 minutes after all patients were switched to conventional oxygen therapy at 5 L/min for the first time, once breathing had stabilized.
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Consistency of diaphragmatic excursion measurements between the standard position and the other four positions on the left side.
Временное ограничение: Measurements were performed 5 minutes after all patients were switched to conventional oxygen therapy at 5 L/min for the first time, once breathing had stabilized.
|
Consistency of measurement methods,Measurements were performed after switching patients in the invasive group (intubated patients to T-piece oxygen at 5 L/min and tracheostomized patients to face mask oxygen at 5 L/min following weaning), and patients in the non-invasive group (those receiving non-invasive ventilation or high-flow oxygen therapy) to conventional face mask oxygen at 5 L/min.
|
Measurements were performed 5 minutes after all patients were switched to conventional oxygen therapy at 5 L/min for the first time, once breathing had stabilized.
|
|
Consistency of diaphragmatic excursion measurements between the standard position and the other five positions on the right side.
Временное ограничение: Measurements were performed 5 minutes after all patients were switched to conventional oxygen therapy at 5 L/min for the first time, once breathing had stabilized.
|
Consistency of measurement methods,Measurements were performed after switching patients in the invasive group (intubated patients to T-piece oxygen at 5 L/min and tracheostomized patients to face mask oxygen at 5 L/min following weaning), and patients in the non-invasive group (those receiving non-invasive ventilation or high-flow oxygen therapy) to conventional face mask oxygen at 5 L/min.
|
Measurements were performed 5 minutes after all patients were switched to conventional oxygen therapy at 5 L/min for the first time, once breathing had stabilized.
|
Соавторы и исследователи
Спонсор
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
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- B2026-162
Планирование данных отдельных участников (IPD)
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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.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .