- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05175313
Transthoracic Ultrasonography Findings and Their Relation to Spirometric Indices in Patients With Obstructive and Restrictive Respiratory Diseases
April 10, 2023 updated by: Esraa Faragallah Abdelaal, Sohag University
Evaluation of respiratory function is considered a crucial component in the assessment of patients with a wide range of respiratory diseases.
Spirometry is considered a common method of measuring pulmonary function.
Recently, Transthoracic ultrasound yields important diagnostic information within minutes.
Respiratory muscle ultrasound is used to evaluate the anatomy and function of the respiratory system.
Study Overview
Status
Recruiting
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Sohag, Egypt
- Recruiting
- Sohag University Hospital
-
-
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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Sampling Method
Probability Sample
Study Population
COPD: include patients with chronic bronchitis and emphysema.
asthma: patients with paroxysmal attacks of chest tightness .wheezes
and cough.
ILD(interstitial lung diseases )
Description
Inclusion Criteria:
1 -age >18 years 2-patients diagnosed with COPD or asthma. 3-patients diagnosed with ILD or any other restrictive lung diseases. 4-normal people.
Exclusion Criteria:
- age <18 years old.
- critically ill patients in intensive care units.
- patients with neurological diseases.
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
normal people
people who don't complain of respiratory diseases will be examined by chest ultrasound and pulmonary function test.
|
pulmonary function test : FVC, FEV1, FEV1/FVC will be measured.
|
|
obstructive respiratory diseases
the patients who are diagnosed with either COPD or asthma.
|
pulmonary function test : FVC, FEV1, FEV1/FVC will be measured.
|
|
restrictive respiratory diseases
patient with either ILD
|
pulmonary function test : FVC, FEV1, FEV1/FVC will be measured.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
investigate the correlation between transthoracic ultrasonography findings and their relation to spirometric indices in patients with different respiratory diseases.
Time Frame: 6months
|
we will study the degree of change in lung ultrasound, diaphragm, and respiratory muscles ultrasound, inferior vena cava ultrasound in obstructive and restrictive respiratory diseases .also,
we find their correlation with spirometric indices in these diseases.
|
6months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Santana PV, Cardenas LZ, Albuquerque ALP, Carvalho CRR, Caruso P. Diaphragmatic ultrasound: a review of its methodological aspects and clinical uses. J Bras Pneumol. 2020 Nov 20;46(6):e20200064. doi: 10.36416/1806-3756/e20200064. eCollection 2020.
- Smargiassi A, Inchingolo R, Tagliaboschi L, Di Marco Berardino A, Valente S, Corbo GM. Ultrasonographic assessment of the diaphragm in chronic obstructive pulmonary disease patients: relationships with pulmonary function and the influence of body composition - a pilot study. Respiration. 2014;87(5):364-71. doi: 10.1159/000358564. Epub 2014 Apr 11.
- O'Hara DN, Pavlov A, Taub E, Ahmad S. Ultrasonographic modeling of diaphragm function: A novel approach to respiratory assessment. PLoS One. 2020 Mar 12;15(3):e0229972. doi: 10.1371/journal.pone.0229972. eCollection 2020.
- Santana PV, Cardenas LZ, de Albuquerque ALP, de Carvalho CRR, Caruso P. Diaphragmatic ultrasound findings correlate with dyspnea, exercise tolerance, health-related quality of life and lung function in patients with fibrotic interstitial lung disease. BMC Pulm Med. 2019 Oct 21;19(1):183. doi: 10.1186/s12890-019-0936-1.
- Zanforlin A, Giannuzzi R, Nardini S, Testa A, Soldati G, Copetti R, Marchetti G, Valente S, Inchingolo R, Smargiassi A. The role of chest ultrasonography in the management of respiratory diseases: document I. Multidiscip Respir Med. 2013 Aug 9;8(1):54. doi: 10.1186/2049-6958-8-54.
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 (Actual)
January 1, 2023
Primary Completion (Anticipated)
June 1, 2023
Study Completion (Anticipated)
June 1, 2023
Study Registration Dates
First Submitted
December 14, 2021
First Submitted That Met QC Criteria
December 14, 2021
First Posted (Actual)
January 3, 2022
Study Record Updates
Last Update Posted (Actual)
April 12, 2023
Last Update Submitted That Met QC Criteria
April 10, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Soh-Med-21-12-15
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
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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