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

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

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

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Device: ultrasonography

Detailed 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)

• Study Type: Observational
• Enrollment (Actual): 80

Contacts and Locations

Study Locations

• Egypt
  • Fayoum, Egypt
    • Fayoum University hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

• Sampling Method: Probability Sample

Study Population

40 COPD patients and 40 age matched healthy control

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
40 COPD patients; all participants were subjected to : history - clinical examination - spirometry - ultrasound evaluation of diaphragmatic function	Device: ultrasonography; ultrasound assessment of diaphragm function
40 healthy individuals; all participants were subjected to : history - clinical examination - spirometry - ultrasound evaluation of diaphragmatic function	Device: ultrasonography; ultrasound assessment of diaphragm function

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
questionnaires	( modified medical research council and chronic obstructive pulmonary disease assessment test) to detect severity of the disease	1 year study

Collaborators and Investigators

• Sponsor: Enas Sayed Farhat
• Investigators: Principal Investigator: Enas S Farhat, MD, Fayoum University hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 14, 2019
• Primary Completion (Actual): June 14, 2020
• Study Completion (Actual): December 14, 2020

Study Registration Dates

• First Submitted: September 3, 2021
• First Submitted That Met QC Criteria: September 3, 2021
• First Posted (Actual): September 5, 2021

Study Record Updates

• Last Update Posted (Actual): September 30, 2021
• Last Update Submitted That Met QC Criteria: September 27, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: ultrasonography, diaphragm, COPD, Fayoum
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: M 448

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: after the submission is finished, the individual participant data will be shared to other researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No