Clinical trial NCT06634485: Spirometry ,diaphragmatic Ultrasound and Skeletal Muscle Mass in Patients with Chronic Obstructive Pulmonary Disease
Official title: Correlation Between Spirometry ,diaphragmatic Ultrasound and Skeletal Muscle Mass in Patients with Chronic Obstructive Pulmonary Disease : Case Control Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: COPD
Ultrasound Therapy; Complications
Keywords: COPD
Diaphragmatic Ultrasound
Spirometry
Skeletal Muscle Mass
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-10-10
Enrollment: 64
Sex: MALE
Minimum age (years): 41
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Two groups will be enrolled in the study; the first group will include healthy volunteers who aged ≥ 40 years\& the second group will include stable COPD Patients of the same age group

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

Eligibility criteria: 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

Primary outcomes:
measure: to study the correlation between diaphragmatic excursion and FEV1
timeFrame: Day 1
Secondary outcomes:
measure: correlation between diaphragmatic muscle function , skeletal muscle mass and duration of hospital stay
timeFrame: Day 1
Other outcomes:
Locations:
Study officials:
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