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NCT Number: NCT06634485

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

* 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.

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Key information

About this study

  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • Musculoskeletal / neurological disorders
  • diaphragmatic eventration \\ hiatus hernia
  • morbid obesity
  • recent thoracic/abdominal surgeries
  • pregnancy; pleurodesis \\fibrothorax.
  • Group B (study group):-
  • Patients need for non- invasive ventilation.
  • Patients with disorders that may affect diaphragmatic function as
  • Musculoskeletal / neurological disorders
  • diaphragmatic eventration \\ hiatus hernia
  • morbid obesity
  • recent thoracic/abdominal surgeries
  • pregnancy; pleurodesis \\fibrothorax

Treatment and study plan

ultrasound, spirometry

Device

Ultrasound assessment of

  • diaphragmatic excursion:-the probe will be angled medially ,cranially , and dorsally so that the ultrasound beam reaches the posterior third of the diaphragm, in B-mode.Then, then M-mode exploration line will be placed perpendicular to the diaphragmatic dome to obtain maximum excursion .
  • (Tdi) will be measured using a high-frequency linear probe (10 MHz) placed on (ZA).The probe will be angled perpendicular to the lateral chest wall and placed between the midaxillary and anterior axillary lines at the eighth or ninth intercostal space.
  • Quadricep|rectus femoris muscle assessment will be done by placing the transducer perpendicular to the long axis of the thigh.
  • Spirometry:-will be performed thrice by experienced technicians at our pulmonary function laboratory. Patients will be asked to take a maximal inspiration and then to forcefully expel air for as long and as quickly as possible.

Primary outcomes

  1. to study the correlation between diaphragmatic excursion and FEV1

    Time frame: Day 1

    In the COPD group,The aim is to assess the correlation between diaphragmatic excursion and FEV1

Secondary outcomes

  1. correlation between diaphragmatic muscle function , skeletal muscle mass and duration of hospital stay

    Time frame: 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Hoda Ahmed Makhlouf, professor

CONTACT

[email protected]

01001529442

Safaa Mohamed Shazly, resident doctor

CONTACT

[email protected]

01228942380

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Correlation Between Spirometry ,diaphragmatic Ultrasound and Skeletal Muscle Mass in Patients with Chronic Obstructive Pulmonary Disease : Case Control Study

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Oct 10, 2024
Registry last updated
Oct 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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