Lung UltrasoundNCT05175313
Transthoracic Ultrasonography Findings and Their Relation to Spirometric Indices in Patients With Obstructive and Restrictive Respiratory Diseases
An observational study of Lung Ultrasound and Spirometry, run by Sohag University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lung Ultrasound, Spirometry, Respiratory Diseases
- What is being tested?
- transthoracic ultrasonography and spirometry
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2023to Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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 )
Who may be able to join
- 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.
Who cannot join
- age <18 years old.
- critically ill patients in intensive care units.
- patients with neurological diseases.
Trial locations and contacts
1 site in 1 country.
Kamal A Atta, professor contact
Egypt1 site, 1 recruiting
- Recruiting
Sohag university hospital
Sohag
Osama R Elsherif
About this study
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.
- Being tested
- transthoracic ultrasonography, spirometry
- Medical subject headings
- Respiratory Tract Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transthoracic ultrasonographyRadiation
- lung ultrasonography
- Diaphragm and respiratory muscle ultrasound
- inferior vena cava ultrasound
spirometryDevice
pulmonary function test : FVC, FEV1, FEV1/FVC will be measured.
| Study group | Role | What they receive |
|---|---|---|
| normal people | people who don't complain of respiratory diseases will be examined by chest ultrasound and pulmonary function test. Receives: Radiation: transthoracic ultrasonography; Device: spirometry | |
| obstructive respiratory diseases | the patients who are diagnosed with either COPD or asthma. Receives: Radiation: transthoracic ultrasonography; Device: spirometry | |
| restrictive respiratory diseases | patient with either ILD Receives: Radiation: transthoracic ultrasonography; Device: spirometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
investigate the correlation between transthoracic ultrasonography findings and their relation to spirometric indices in patients with different respiratory diseases.
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.
Measured: 6months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2022
- Study start1 Jan 2023
- Primary completionJun 2023 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Lung UltrasoundStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Collaborators
- Cairo University
- Responsible party
- Principal investigator, Esraa Faragallah Abdelaal, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05175313
- Sponsor's protocol ID
- Soh-Med-21-12-15
- Status last verified
- Apr 2023
- First submitted
- 14 Dec 2021
- Last updated
- 12 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 33237154Smargiassi 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.
PubMed 24732295O'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.
PubMed 32163474Santana 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.
PubMed 31638951Zanforlin 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.
PubMed 23937880
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transthoracic Ultrasonography Findings and Their Relation to Spirometric Indices in Patients With Obstructive and Restrictive Respiratory Diseases
- ClinicalTrials.gov ID
- NCT05175313
- Acronym / sponsor ID
- Soh-Med-21-12-15
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Collaborators
- Cairo University
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 3 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| normal people | – | Radiation: transthoracic ultrasonography, Device: spirometrypeople who don't complain of respiratory diseases will be examined by chest ultrasound and pulmonary function test. |
| obstructive respiratory diseases | – | Radiation: transthoracic ultrasonography, Device: spirometrythe patients who are diagnosed with either COPD or asthma. |
| restrictive respiratory diseases | – | Radiation: transthoracic ultrasonography, Device: spirometrypatient with either ILD |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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 )
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- age <18 years old.
- critically ill patients in intensive care units.
- patients with neurological diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transthoracic ultrasonography1. lung ultrasonography 2. Diaphragm and respiratory muscle ultrasound 3. inferior vena cava ultrasound | Radiation | normal people, obstructive respiratory diseases, restrictive respiratory diseases |
| spirometrypulmonary function test : FVC, FEV1, FEV1/FVC will be measured. | Device | normal people, obstructive respiratory diseases, restrictive respiratory diseases |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2023.
- Background: PubMed 33237154Santana 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.
- Background: PubMed 24732295Smargiassi 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.
- Background: PubMed 32163474O'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.
- Background: PubMed 31638951Santana 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.
- Background: PubMed 23937880Zanforlin 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kamal A Atta, professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Ultrasound and Spirometry, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact esraa F Abdelaal, assistant lecturer (01090490019, esraa.faragallah@.med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
investigate the correlation between transthoracic ultrasonography findings and their relation to spirometric indices in patients with different respiratory diseases. (time frame: 6months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05175313, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2023.