DiaphragmNCT06348745
Trans Thoracic Ultrasound to Assess Diaphragmatic Function in Stable COPD Versus Bronchial Asthma.
A study testing ultrasound in people with Diaphragm, run by Assiut University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diaphragm
- What is being tested?
- ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2024to 1 May 2026
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stable patients (not in exacerbation).
Who cannot join
- Patients with comorbidities as cardiac, renal or hepatic diseases.
- Patients who have combined COPD and bronchial asthma.
About this study
- 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.
Read the 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)
- Conditions
- Diaphragm
- Being tested
- ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasoundDevice
- Transthoracic ultrasound for both right and left diaphragm during inspiration and expiration.
| Study group | Role | What they receive |
|---|---|---|
| chronic obstructive pulmonary disease (COPD) | Experimental | ultrasound to COPD patients to asses' diaphragmatic function. Receives: Device: ultrasound |
| bronchial asthma | Experimental | ultrasound to bronchial asthma patients to asses' diaphragmatic function. Receives: Device: ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
diaphragmatic function
Compare diaphragmatic function using ultrasound device by measuring diaphragmatic thickness in both stable COPD and bronchial asthma patients.
Measured: 2 years
Secondary outcomes (1)
pulmonary function .
assess the degree of effect of diaphragmatic dysfunction on pulmonary function measured by spirometry FEV1/FVC (forced expiratory volume1/ forced Vidal capacity )
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2024
- Study start1 Apr 2024 (estimated)
- Primary completion1 Apr 2026 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiaphragmStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Amer, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06348745
- Sponsor's protocol ID
- diaphragmatic ultrasound
- Status last verified
- Apr 2024
- First submitted
- 28 Feb 2024
- Last updated
- 8 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trans Thoracic Ultrasound to Assess Diaphragmatic Function in Stable COPD Versus Bronchial Asthma.
- ClinicalTrials.gov ID
- NCT06348745
- Acronym / sponsor ID
- diaphragmatic ultrasound
- Conditions
- Diaphragm
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (estimated)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 5 Apr 2024 (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.
- 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.
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 design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| chronic obstructive pulmonary disease (COPD) | Experimental | Device: ultrasoundultrasound to COPD patients to asses' diaphragmatic function. |
| bronchial asthma | Experimental | Device: ultrasoundultrasound to bronchial asthma patients to asses' diaphragmatic function. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Stable patients (not in exacerbation).
Key exclusion criteria (2 listed)
- Patients with comorbidities as cardiac, renal or hepatic diseases.
- Patients who have combined COPD and bronchial asthma.
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 |
|---|---|---|
| ultrasound5. Transthoracic ultrasound for both right and left diaphragm during inspiration and expiration. | Device | bronchial asthma, chronic obstructive pulmonary disease (COPD) |
Primary outcome
diaphragmatic function
Time frame: 2 years
Compare diaphragmatic function using ultrasound device by measuring diaphragmatic thickness in both stable COPD and bronchial asthma patients.
1 secondary outcome
pulmonary function .
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing ultrasound in people with Diaphragm, run by Assiut University.
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 2 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 8 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
diaphragmatic function (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Apr 2024.