Nutritional Risk and Diaphragmatic Thickness in Mechanically Ventilated COPD Patients

NCT07788170 | Not Yet Recruiting

• 1 other identifier: Nutrition & Diaphragm in COPD
• Study Type: observational
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Chronic Obstructive Pulmonary Disease (COPD); Acute Exacerbation of Chronic Obstructive Pulmonary Disease; Malnutrition; Respiratory Failure; Ventilator-Induced Diaphragmatic Dysfunction

Keywords

modified NUTRIC score; Diaphragmatic ultrasound; Diaphragm thickness; Mechanical ventilation; Mid-upper arm circumference; Calf circumference; Sarcopenia; Weaning failure; APACHE II; SOFA score

Outcome Measures

Primary Outcomes (1)

• 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).

  Baseline

Study Arms (1)

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.

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Malnutrition; Respiratory Insufficiency; Sarcopenia

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nutrition Disorders; Nutritional and Metabolic Diseases; Respiration Disorders; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Chest Diseases

Study Record Dates

• First Submitted: August 22, 2026
• First Posted: August 26, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: August 26, 2026

Record last verified: 2026-08