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Nutritional Risk and Diaphragmatic Thickness in Mechanically Ventilated COPD Patients

2026年8月22日 更新者: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.

調査の概要

詳細な説明

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.

研究の種類

観察的

入学 (推定)

120

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

なし

サンプリング方法

非確率サンプル

調査対象母集団

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.

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

コホートと介入

グループ/コホート
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.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Baseline End-Expiratory Diaphragmatic Thickness
時間枠: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

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スポンサー

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年10月1日

一次修了 (推定)

2027年10月1日

研究の完了 (推定)

2027年11月1日

試験登録日

最初に提出

2026年8月22日

QC基準を満たした最初の提出物

2026年8月22日

最初の投稿 (実際)

2026年8月26日

学習記録の更新

投稿された最後の更新 (実際)

2026年8月26日

QC基準を満たした最後の更新が送信されました

2026年8月22日

最終確認日

2026年8月1日

詳しくは

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