Chronic Obstructive Pulmonary DiseaseNCT05035875
Evaluation of Diaphragm in Chronic Obstructive Pulmonary Disease Patients by Ultrasound in Relation to Severity
An observational study of Chronic Obstructive Pulmonary Disease, run by Enas Sayed Farhat at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- ultrasonography
- Type of treatment
- Medical device
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 14 Dec 2019to 14 Dec 2020
- 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 40 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: 40 COPD patients and 40 age matched healthy control
Who may be able to join
- • 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
Who cannot join
- • Patient with a known neuromuscular disorder.
- Patient with known anatomical malformation of the diaphragm.
- Post abdominal or thoracic surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Diaphragm in Chronic Obstructive Pulmonary Disease Patients Using Ultrasonography in Relation to Disease Severity in Fayoum University Hospital
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
Read the 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)
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- ultrasonography
- Keywords
- ultrasonography, diaphragm, COPD, Fayoum
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasonographyDevice
ultrasound assessment of diaphragm function
| Study group | Role | What they receive |
|---|---|---|
| 40 COPD patients | all participants were subjected to : history - clinical examination - spirometry - ultrasound evaluation of diaphragmatic function Receives: Device: ultrasonography | |
| 40 healthy individuals | all participants were subjected to : history - clinical examination - spirometry - ultrasound evaluation of diaphragmatic function Receives: Device: ultrasonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
measure diaphragmatic thickness by ultrasound
measure diaphragmatic thickness at total lung capacity and residual volume in millimetres to calculate diaphragm thickness fraction
Measured: 1 year study
measure diaphragm excursion by ultrasound
measure diaphragm excursion in centimetres at zone of apposition
Measured: 1 year study
Secondary outcomes (2)
spirometry assessment
value of forced expiratory volume in first second is assessed as a percentage of normal by spirometry to assess disease severity
Measured: 1 year study
questionnaires
( modified medical research council and chronic obstructive pulmonary disease assessment test) to detect severity of the disease
Measured: 1 year study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2021
- Study start14 Dec 2019
- Primary completion14 Jun 2020
- Study completion14 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- 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
- Cross-sectional
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Enas Sayed Farhat
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Enas Sayed Farhat, Fayoum University Hospital
- Investigators
- Enas S Farhat, MD, Principal investigator, Fayoum University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05035875
- Sponsor's protocol ID
- M 448
- Status last verified
- Sep 2021
- First submitted
- 3 Sep 2021
- Last updated
- 30 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: after the submission is finished, the individual participant data will be shared to other researchers
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Diaphragm in Chronic Obstructive Pulmonary Disease Patients Using Ultrasonography in Relation to Disease Severity in Fayoum University Hospital
- ClinicalTrials.gov ID
- NCT05035875
- Acronym / sponsor ID
- M 448
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- ultrasonography, diaphragm, COPD, Fayoum
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Enas Sayed FarhatUniversity, hospital or other
- Study start
- 14 Dec 2019 (actual)
- Primary completion
- 14 Jun 2020 (actual)
- Study completion
- 14 Dec 2020 (actual)
- First posted
- 5 Sep 2021 (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.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 40 COPD patients | – | Device: ultrasonographyall participants were subjected to : history - clinical examination - spirometry - ultrasound evaluation of diaphragmatic function |
| 40 healthy individuals | – | Device: ultrasonographyall participants were subjected to : history - clinical examination - spirometry - ultrasound evaluation of diaphragmatic function |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 40 COPD patients and 40 age matched healthy control
Key inclusion criteria (2 listed)
- • Stable COPD patients aged more than 40 years who were diagnosed and classified into four groups of severity according to GOLD 2020.
Key exclusion criteria (3 listed)
- • Patient with a known neuromuscular disorder.
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 |
|---|---|---|
| ultrasonographyultrasound assessment of diaphragm function | Device | 40 COPD patients, 40 healthy individuals |
Primary outcome
measure diaphragmatic thickness by ultrasound
Time frame: 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
Time frame: 1 year study
measure diaphragm excursion in centimetres at zone of apposition
2 secondary outcomes
spirometry assessment
Time frame: 1 year study
questionnaires
Time frame: 1 year study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2021.
- Individual participant dataSharing planned: No. after the submission is finished, the individual participant data will be shared to other researchers
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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.
Enas S Farhat, MD principal investigator
Fayoum University Hospital
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 Chronic Obstructive Pulmonary Disease, run by Enas Sayed Farhat 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 2 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: finished, as of the sponsor's last update on 30 Sep 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
measure diaphragmatic thickness by ultrasound (time frame: 1 year study). The study lists 2 primary outcomes in all. 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 30 Sep 2021.