Spirometry ,diaphragmatic Ultrasound and Skeletal Muscle Mass in Patients with Chronic Obstructive Pulmonary Disease

Not yet recruiting

• Conditions: COPD; Ultrasound Therapy; Complications
• Interventions: Device: ultrasound, spirometry

• Registration Number: NCT06634485
• Lead Sponsor: Assiut University

Brief Summary

* The primary objective is to evaluate the use of diaphragmatic function and skeletal muscle mass by ultrasound as a tool to establish the diagnosis of COPD and assess the severity of the disease.

* The secondary objective is to compare diaphragmatic function, Skeletal muscle mass, and spirometry results in patients with COPD.

Detailed Description

* Chronic obstructive pulmonary disease (COPD) is a common preventable and treatable disease as per the Global Initiative for Chronic Obstructive Lung Disease (GOLD) and is characterized by persistent respiratory symptoms and airflow limitation that is due to airway and/or alveolar abnormalities usually caused by significant exposure to noxious particles or gases. According to the GOLD report, COPD is projected to be the third leading cause of death by 2020, and currently, it is the fourth .

* COPD is characterized by worsening dyspnea during movement . COPD restricts various activities of daily living due to shortness of breath, leading to poor quality of life and increased mortality and morbidity .

* COPD impairs the function of diaphragm which is the primary muscle of inspiration. Diaphragm provides 75% of the increase in lung volume during quiet inspiration .

* Movement of diaphragm during breathing is called diaphragm mobility. Movement of diaphragm from end-expiration to full inspiration is known as diaphragm excursion.

* Diaphragmatic mobility is lower in patients with COPD than in healthy individuals . Hence it is necessary to assess diaphragm function in inpatients and outpatients diagnosed with COPD during emergencies.

* Skeletal muscle dysfunction is a frequent and clinically relevant systemic manifestation of COPD that predicts morbidity and mortality independently from the severity of lung function impairment as judged by forced expiratory volume in 1 s (FEV1).Even in non cachectic patients with COPD, quadriceps strength is typically reduced by up to 30% compared with healthy elderly participants. Quadriceps strength independently predicts increased health-care utilization and mortality in COPD. While CT and magnetic resonance imaging (MRI) of the quadriceps have been studied in COPD, ultrasound use to assess limb muscle size has recently emerged as a newer, comparable, and noninvasive modality .

* Ultrasonography is a cost-effective, radiation-free, widely available, and real-time investigation.Many studies have proposed the possible use of ultrasonography to measure the diaphragmatic excursion .

* Spirometry is a noninvasive, easy, and valid tool for COPD assessment. There are established criteria based on spirometry, according to which COPD can be classified as mild, moderate, severe, and very severe .

There is a limited data about the association between spirometry, diaphragmatic excursion and skeletal muscle mass in patients with chronic obstructive pulmonary disease and further studies are needed

Study Timeline

• Status Verified: 2024-08
• Study First Submitted: 2024-08-21
• Study First Submitted QC: 2024-10-08
• Last Update Submitted: 2024-10-08
• Study Start: 2024-10-10
• Study First Posted: 2024-10-10
• Last Update Posted: 2024-10-10
• Primary Completion: 2026-09-01
• Study Completion: 2026-12-20

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 64

Inclusion Criteria

• Group A (control group):

  • This group include healthy volunteers who aged ≥ 40 years .

• Group B (study group):

  • This include stable COPD Patients who will be diagnosed by GOLD 2024 and last excerbation ≥ 6weeks .

Exclusion Criteria

• Group A (control group):

  • Patients with disorders that may affect diaphragmatic function as

    1. Musculoskeletal / neurological disorders
    2. diaphragmatic eventration \ hiatus hernia
    3. morbid obesity
    4. recent thoracic/abdominal surgeries
    5. pregnancy; pleurodesis \fibrothorax.

• Group B (study group):-

  • Patients need for non- invasive ventilation.

  • Patients with disorders that may affect diaphragmatic function as

    1. Musculoskeletal / neurological disorders
    2. diaphragmatic eventration \ hiatus hernia
    3. morbid obesity
    4. recent thoracic/abdominal surgeries
    5. pregnancy; pleurodesis \fibrothorax

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
control group	ultrasound, spirometry	This group include healthy volunteers who aged ≥ 40 years .
study group	ultrasound, spirometry	This include stable COPD Patients who will be diagnosed by GOLD 2024 and last excerbation ≥ 6weeks .

Primary Outcome Measures

Name	Time	Method
to study the correlation between diaphragmatic excursion and FEV1	Day 1	In the COPD group,The aim is to assess the correlation between diaphragmatic excursion and FEV1

Secondary Outcome Measures

Name	Time	Method
correlation between diaphragmatic muscle function , skeletal muscle mass and duration of hospital stay	Day 1	correlation between diaphragmatic excursion measured by thoracic ultrasound in cm , quadriceps muscle thickness measured by ultrasound in cm and duration of hospital stay (in days)