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Nutritional Risk and Diaphragmatic Thickness in Mechanically Ventilated COPD Patients

22 de agosto de 2026 atualizado por: Ziad Mohamed Esmail Abdel-Aal, Assiut University

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.

Visão geral do estudo

Descrição detalhada

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.

Tipo de estudo

Observacional

Inscrição (Estimado)

120

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

N/D

Método de amostragem

Amostra Não Probabilística

População do estudo

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.

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Coortes e Intervenções

Grupo / Coorte
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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Baseline End-Expiratory Diaphragmatic Thickness
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

1 de outubro de 2026

Conclusão Primária (Estimado)

1 de outubro de 2027

Conclusão do estudo (Estimado)

1 de novembro de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

22 de agosto de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

22 de agosto de 2026

Primeira postagem (Real)

26 de agosto de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

26 de agosto de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

22 de agosto de 2026

Última verificação

1 de agosto de 2026

Mais Informações

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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