Trans Thoracic Ultrasound to Assess Diaphragmatic Function in Stable COPD Versus Bronchial Asthma.

April 5, 2024 updated by: Sara Amer, Assiut University
  • Assessment of diaphragmatic function (excursion, thickness variation, thickness ratio) in COPD and bronchial asthma patients.
  • Assessment of presence of correlation between diaphragmatic dysfunction and pulmonary function.
  • Assessment of possible association between diaphragmatic dysfunction and presence of reversibility in pulmonary function post bronchodilator.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

  • Assessment of diaphragmatic function (excursion, thickness variation, thickness ratio) in COPD and bronchial asthma patients.
  • Assessment of presence of correlation between diaphragmatic dysfunction and pulmonary function (FEV1/FVC).
  • Assessment of possible association between diaphragmatic dysfunction and presence of reversibility in pulmonary function post bronchodilator (short acting B2 agonist)

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Stable patients (not in exacerbation).

Exclusion Criteria:

  • Patients with comorbidities as cardiac, renal or hepatic diseases.
  • Patients who have combined COPD and bronchial asthma.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: chronic obstructive pulmonary disease (COPD)
ultrasound to COPD patients to asses' diaphragmatic function.
Device: ultrasound
5. Transthoracic ultrasound for both right and left diaphragm during inspiration and expiration.
Experimental: bronchial asthma
ultrasound to bronchial asthma patients to asses' diaphragmatic function.
Device: ultrasound
5. Transthoracic ultrasound for both right and left diaphragm during inspiration and expiration.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
diaphragmatic function
Time Frame: 2 years
Compare diaphragmatic function using ultrasound device by measuring diaphragmatic thickness in both stable COPD and bronchial asthma patients.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pulmonary function .
Time Frame: 2 years
assess the degree of effect of diaphragmatic dysfunction on pulmonary function measured by spirometry FEV1/FVC (forced expiratory volume1/ forced Vidal capacity )
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2024

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

February 28, 2024

First Submitted That Met QC Criteria

March 30, 2024

First Posted (Actual)

April 5, 2024

Study Record Updates

Last Update Posted (Actual)

April 8, 2024

Last Update Submitted That Met QC Criteria

April 5, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • diaphragmatic ultrasound

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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