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

NCT05035875 | Completed

• 1 other identifier: M 448
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

ultrasonography, diaphragm, COPD, Fayoum

Outcome Measures

Primary Outcomes (2)

• 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

• measure diaphragm excursion by ultrasound

  measure diaphragm excursion in centimetres at zone of apposition

  1 year study

Secondary Outcomes (2)

• spirometry assessment

  1 year study

• questionnaires

  1 year study

Study Arms (2)

40 COPD patients

all participants were subjected to : history - clinical examination - spirometry - ultrasound evaluation of diaphragmatic function

Device: ultrasonography

40 healthy individuals

all participants were subjected to : history - clinical examination - spirometry - ultrasound evaluation of diaphragmatic function

Device: ultrasonography

Interventions

ultrasonography DEVICE

ultrasound assessment of diaphragm function

40 COPD patients; 40 healthy individuals

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

40 COPD patients and 40 age matched healthy control

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Enas Sayed Farhat: lead

Study Sites (1)

Fayoum University Hospital

Al Fayyum, Egypt

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Enas S Farhat, MD

  Fayoum University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: fayoum university hospital

Study Record Dates

• First Submitted: September 3, 2021
• First Posted: September 5, 2021
• Study Start: December 14, 2019
• Primary Completion: June 14, 2020
• Study Completion: December 14, 2020
• Last Updated: September 30, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)