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

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05035875
• Other study ID #: M 448
• Status: Completed
• 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
• 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.

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

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