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

Completed

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Device: ultrasonography

• Registration Number: NCT05035875
• Lead Sponsor: Enas Sayed Farhat

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

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 Timeline

• Study Start: 2019-12-14
• Primary Completion: 2020-06-14
• Study Completion: 2020-12-14
• Status Verified: 2021-09
• Study First Submitted: 2021-09-03
• Study First Submitted QC: 2021-09-03
• Study First Posted: 2021-09-05
• Last Update Submitted: 2021-09-27
• Last Update Posted: 2021-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 80

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
40 COPD patients	ultrasonography	all participants were subjected to : history - clinical examination - spirometry - ultrasound evaluation of diaphragmatic function
40 healthy individuals	ultrasonography	all participants were subjected to : history - clinical examination - spirometry - ultrasound evaluation of diaphragmatic function

Primary Outcome Measures

Name	Time	Method
measure diaphragmatic thickness by ultrasound	1 year study	measure diaphragmatic thickness at total lung capacity and residual volume in millimetres to calculate diaphragm thickness fraction
measure diaphragm excursion by ultrasound	1 year study	measure diaphragm excursion in centimetres at zone of apposition

Secondary Outcome Measures

Name	Time	Method
spirometry assessment	1 year study	value of forced expiratory volume in first second is assessed as a percentage of normal by spirometry to assess disease severity
questionnaires	1 year study	( modified medical research council and chronic obstructive pulmonary disease assessment test) to detect severity of the disease

Trial Locations

Locations (1)

Fayoum University Hospital; 🇪🇬 Fayoum, Egypt