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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05035875
Other study ID # M 448
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 14, 2019
Est. completion date December 14, 2020

Study information

Verified date September 2021
Source Fayoum University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


Description:

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)


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date December 14, 2020
Est. primary completion date June 14, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 40 Years to 60 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
ultrasonography
ultrasound assessment of diaphragm function

Locations

Country Name City State
Egypt Fayoum University Hospital Fayoum

Sponsors (1)

Lead Sponsor Collaborator
Enas Sayed Farhat

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary measure diaphragmatic thickness by ultrasound measure diaphragmatic thickness at total lung capacity and residual volume in millimetres to calculate diaphragm thickness fraction 1 year study
Primary measure diaphragm excursion by ultrasound measure diaphragm excursion in centimetres at zone of apposition 1 year study
Secondary spirometry assessment value of forced expiratory volume in first second is assessed as a percentage of normal by spirometry to assess disease severity 1 year study
Secondary questionnaires ( modified medical research council and chronic obstructive pulmonary disease assessment test) to detect severity of the disease 1 year study
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