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Completed

NCT Number: NCT05035875

Evaluation of Diaphragm in Chronic Obstructive Pulmonary Disease Patients by Ultrasound in Relation to Severity

The study of the diaphragm is an important point in the assessment of COPD patients.

Ultrasonographic evaluation of the diaphragm is considered a simple, non-invasive, available bedside technique. Ultrasonography can be used for evaluation of the site, structure, and motion of the diaphragm, assessment of excursion, and thickness.

The aim of the study is ultrasonographic assessment of the diaphragm in COPD patients and its relation to disease severity

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Key information

Conditions

Chronic Obstructive Pulmonary Disease Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year–60 year

Sex eligibility

Male

Study type

Observational

Primary location

Fayoum University Hospital

Al Fayyum, Egypt

About this study

The study was conducted on eighty patients, forty COPD patients who were diagnosed and classified into four groups according as following: The first group: included 10 patients with a mild stage. The second group: included 10 patients with a moderate stage. The third group: included 10 patients with a severe stage. The fourth group: included 10 patients with a very severe stage. The study also included forty healthy individuals of the same age and sex as COPD patients. All participants gave their informed consent for inclusion before sharing in the study. Every person was submitted to: Full medical history, Clinical examination,Chest x-ray, spirometry and ultrasonographic assessment of diaphragm function (thickness and excursion)

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • • Stable COPD patients aged more than 40 years who were diagnosed and classified into four groups of severity according to GOLD 2020.
  • Age and sex-matched healthy controls

Exclusion criteria

  • • Patient with a known neuromuscular disorder.
  • Patient with known anatomical malformation of the diaphragm.
  • Post abdominal or thoracic surgery.

Treatment and study plan

Ultrasonography

Device

ultrasound assessment of diaphragm function

Primary outcomes

  1. measure diaphragmatic thickness by ultrasound

    Time frame: 1 year study

    measure diaphragmatic thickness at total lung capacity and residual volume in millimetres to calculate diaphragm thickness fraction

  2. measure diaphragm excursion by ultrasound

    Time frame: 1 year study

    measure diaphragm excursion in centimetres at zone of apposition

Secondary outcomes

  1. spirometry assessment

    Time frame: 1 year study

    value of forced expiratory volume in first second is assessed as a percentage of normal by spirometry to assess disease severity

  2. questionnaires

    Time frame: 1 year study

    ( modified medical research council and chronic obstructive pulmonary disease assessment test) to detect severity of the disease

Sponsors and collaborators

Lead sponsor

Enas Sayed Farhat

Other

Registry information

Official study title

Evaluation of Diaphragm in Chronic Obstructive Pulmonary Disease Patients Using Ultrasonography in Relation to Disease Severity in Fayoum University Hospital

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Sep 5, 2021
Registry last updated
Sep 30, 2021

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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