Nutritional Risk and Diaphragmatic Thickness in Mechanically Ventilated COPD Patients
Nutritional Risk Assessment and Diaphragmatic Thickness for Predicting Outcome in Elderly Mechanically Ventilated COPD Patients
Malnutrition and muscle wasting are frequent complications in patients with chronic obstructive pulmonary disease (COPD) experiencing acute exacerbations. In critically ill patients who require invasive mechanical ventilation, nutritional depletion and ventilator-induced diaphragmatic dysfunction can complicate recovery and prolong intensive care unit (ICU) stays.
The purpose of this prospective observational cohort study is to evaluate nutritional status and diaphragmatic structure in elderly patients (aged 60 years and older) with COPD who require invasive mechanical ventilation for at least 48 hours.
Participants will undergo bedside assessments, including:
- Calculation of clinical risk scores within the first 24 hours of ICU admission: modified Nutrition Risk in the Critically Ill (mNUTRIC), Sequential Organ Failure Assessment (SOFA), and Acute Physiology and Chronic Health Evaluation II (APACHE II).
- Anthropometric measurements: mid-upper arm circumference (MUAC) and calf circumference (CC) measured at baseline, day 7, and the day of weaning.
- Diaphragmatic ultrasonography: point-of-care ultrasound to measure diaphragm thickness at end-expiration and end-inspiration at baseline, day 7, and during weaning trials.
The main goal is to evaluate the relationship between nutritional risk (assessed by the mNUTRIC score) and diaphragmatic thickness, and to determine how these parameters correlate with clinical outcomes such as weaning success, total duration of mechanical ventilation, ICU length of stay, and ICU mortality.
Обзор исследования
Статус
Подробное описание
Malnutrition is a prevalent comorbidity in chronic obstructive pulmonary disease (COPD) associated with lower exercise tolerance, decreased pulmonary function, and increased mortality. In the intensive care unit (ICU), acute exacerbations requiring invasive mechanical ventilation frequently lead to accelerated muscle wasting and ventilator-induced diaphragmatic dysfunction. Combining bedside clinical risk scoring, peripheral anthropometry, and diaphragmatic ultrasonography provides a comprehensive approach to evaluating nutritional and functional reserve.
Eligible patients aged 60 years or older admitted with acute exacerbations of COPD requiring invasive mechanical ventilation for at least 48 hours will be prospectively enrolled.
Clinical and Severity Scoring (Day 1): Within the first 24 hours of admission and ventilation initiation, baseline demographic data, arterial blood gases, and severity scores will be recorded. Scores include the modified Nutrition Risk in the Critically Ill (mNUTRIC; range 0-9, where ≥ 5 defines high nutritional risk), Sequential Organ Failure Assessment (SOFA; range 0-24), and Acute Physiology and Chronic Health Evaluation II (APACHE II; range 0-71).
Anthropometric Measurements: Mid-upper arm circumference (MUAC) and calf circumference (CC) will be performed by a single investigator using a non-stretchable measuring tape recorded to the nearest 0.1 cm. Values will be obtained at baseline (within 24 hours), day 7 (or at extubation/discharge if earlier), and on the day of weaning.
Diaphragmatic Ultrasonography: Bedside point-of-care ultrasound using a high-frequency linear probe (7-13 MHz) will evaluate the diaphragm in the zone of apposition at the 8th-9th intercostal space on the right hemithorax. Diaphragm thickness at end-expiration (Tdi,ee) and end-inspiration (Tdi,pi) will be measured in B-mode/M-mode (averaging three consecutive cycles) at baseline, day 7, and during spontaneous breathing trials/weaning attempts.
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:
- Adult patients aged ≥ 60 years
- Confirmed diagnosis of Chronic Obstructive Pulmonary Disease (COPD) according to GOLD (Global Initiative for Chronic Obstructive Lung Disease) criteria
- Admission to the intensive care unit (ICU) or respiratory ICU for acute exacerbation of COPD
- Requirement for invasive mechanical ventilation for ≥ 48 hours
- Provision of informed consent by the patient or a first-degree relative/legal guardian
Exclusion Criteria:
- Pre-existing neuromuscular disease affecting diaphragmatic or peripheral muscle function (e.g., myasthenia gravis, muscular dystrophy, poliomyelitis, motor neuron disease)
- Known diaphragmatic paralysis or phrenic nerve injury predating admission
- Severe limb edema, amputation, or lower-limb deformity precluding valid anthropometric measurement
- Terminal illness or malignancy with an expected survival of < 48 hours
- Duration of mechanical ventilation < 48 hours, or death/extubation occurring before baseline assessment completion
- Subcutaneous emphysema or thoracic/abdominal wall pathology precluding adequate diaphragmatic ultrasound acoustic windows
Учебный план
Как устроено исследование?
Детали дизайна
Когорты и вмешательства
Группа / когорта |
|---|
|
Mechanically Ventilated Elderly COPD Patients
Adult patients aged 60 years or older with a confirmed diagnosis of COPD admitted to the ICU/respiratory ICU for acute exacerbation and requiring invasive mechanical ventilation for at least 48 hours.
Participants undergo baseline severity scoring (mNUTRIC, SOFA, APACHE II), serial anthropometric assessments (MUAC, calf circumference), and diaphragmatic ultrasonography (diaphragm thickness at end-expiration and end-inspiration) at baseline, day 7, and during spontaneous breathing trials/weaning.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Baseline End-Expiratory Diaphragmatic Thickness
Временное ограничение: Baseline
|
Diaphragm thickness measured in millimeters (mm) at end-expiration (Tdi,ee) using B-mode/M-mode bedside ultrasonography in the zone of apposition (8th-9th intercostal space between the anterior and mid-axillary lines).
The average of three consecutive measurements will be reported and evaluated in relation to the baseline modified NUTRIC score (scores range from 0 to 9, where scores ≥ 5 indicate high nutritional risk).
|
Baseline
|
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
- Неврологические проявления
- Заболевания нервной системы
- Нервно-мышечные проявления
- Патологические процессы
- Расстройства питания
- Патологические состояния, анатомические
- Хроническое заболевание
- Атрибуты болезни
- Заболевания дыхательных путей
- Легочные заболевания
- Нарушения дыхания
- Заболевания легких, обструктивные
- Мышечная атрофия
- Атрофия
- Патологические состояния, признаки и симптомы
- Пищевые и метаболические заболевания
- Признаки и симптомы
- Недоедание
- Легочные заболевания, хроническая обструктивная
- Дыхательная недостаточность
- Саркопения
Другие идентификационные номера исследования
- Nutrition & Diaphragm in COPD
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. .