About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Elderly patients aged 60 years or older with acute exacerbation of chronic obstructive pulmonary disease (COPD) admitted to the Chest Department and ICU/respiratory ICU at Assiut University Hospital who require invasive mechanical ventilation for at least 48 hours.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Baseline End-Expiratory Diaphragmatic Thickness
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).
Locations
Sponsors and contacts
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