COPDNCT06983366
Validation and Clinical Utility of the Lung Sliding Index (LSI) for Differentiating Pulmonary Diseases
An observational study of COPD and ILD, run by Assiut University at 1 site in Egypt.
Trial summary
This upcoming case-control study aims to confirm the Lung Sliding Index (LSI), a new ultrasound score that measures how well the pleura moves, in various lung diseases. The study will check how well the LSI can tell apart different lung diseases (like pneumothorax, interstitial lung disease, COPD, pneumonia, and… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COPD, ILD, Bronchiectasis
- What is being tested?
- Lung Ultrasound
- How many people
- 700 participants
- Where
- 1 siteEgypt
- Study dates
- 30 May 2025to 1 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Adult patients (>18 years) with: * Pneumothorax * Interstitial lung disease (ILD/IPF) * COPD/emphysema * Bronchiectasis * Community-acquired pneumonia * Pulmonary edema * Pleural effusion * Healthy controls
Who may be able to join
- Age 18 years and older.
- Diagnosed with one of the specified pulmonary diseases, or a healthy control
- Able to provide written informed consent
Who cannot join
- Inability to tolerate or undergo a lung ultrasound
- Extensive chest wall pathology precluding assessment
- Unscorable >2 zones per protocol
- Withdrawal of consent
- Mechanically-ventilated patients
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Assiut University- Faculty of Medicine
Asyut, 71515
Ahmad M. Shaddad, MD, +201111171939, Shaddad_ahmad@aun.edu.eg
Ahmad M. Shaddad, MD
About this study
Official title: Validation and Clinical Utility of the Lung Sliding Index (LSI) for Differentiating Pulmonary Diseases: A Prospective Case-Control Study
This upcoming case-control study aims to confirm the Lung Sliding Index (LSI), a new ultrasound score that measures how well the pleura moves, in various lung diseases. The study will check how well the LSI can tell apart different lung diseases (like pneumothorax, interstitial lung disease, COPD, pneumonia, and pulmonary edema), how it relates to signs of disease severity, and how consistent the results are between different operators who have received the same training. Secondary objectives include assessing patient and operator satisfaction and feasibility using validated Likert scales.
Read the detailed description
- The study will enroll adults with various pulmonary pathologies and healthy controls. Lung ultrasound will be performed on all subjects using a standardized 12-zone protocol; each zone will be scored for pleural sliding using the LSI (0-3 per zone; total 0-36). Operator training and calibration will precede enrollment to ensure scoring consistency.
- A subset of patients will undergo repeat assessments to evaluate intra- and interobserver reliability, using independent, blinded raters.
- For correlation with LSI, we will collect clinical data, including spirometry, blood gases, symptom scores, and 6-minute walk tests. Diagnostic utility will be evaluated using ROC curves. Satisfaction and feasibility will be assessed via Likert questionnaires, with validation analyses (internal consistency, test-retest reliability).
- All data will be de-identified and securely stored. Written informed consent will be obtained from all participants.
- The study groups will include: 1- Pneumothorax 2. Interstitial lung disease (ILD/IPF) 3. COPD/emphysema 4. Bronchiectasis 5. Community-acquired pneumonia 6. Pulmonary edema 7- Pleural effusion 8. Healthy controls
- Data Collection Methods:
- Standardized data entry forms for clinical, imaging, and outcome data.
- Centralized digital storage with access limited to study personnel.
Statistical Methods:
- Descriptive statistics for baseline data ANOVA or Kruskal-Wallis for group comparisons; post hoc testing as appropriate ROC analysis for diagnostic cut-offs Pearson/Spearman correlation for clinical associations Intraclass correlation coefficients (ICC) for reliability Cronbach's alpha for Likert scale validation Multivariable regression for confounder adjustment
- Conditions
- COPD, ILD, Bronchiectasis, Pneumothorax, Pneumonia, Pleural Effusion Disorder
- Being tested
- Lung Ultrasound
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Bronchiectasis, Pneumothorax, Pneumonia, Pleural Effusion, Pulmonary Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung UltrasoundDiagnostic test
All enrolled patient will be subjected to Lung Ultrasound examination LUS
| Study group | Role | What they receive |
|---|---|---|
| Chronic obstructive pulmonary disease (COPD) | Chronic obstructive pulmonary disease patients will be further classified as mild, moderate, severe, and very severe according to GOLD classification. Receives: Diagnostic Test: Lung Ultrasound | |
| Pneumothorax | Patients with Pneumothorax Receives: Diagnostic Test: Lung Ultrasound | |
| Community-acquired pneumonia (CAP) | Community-acquired pneumonia will be classified using the CURB-65 score into mild, moderate, and severe. Receives: Diagnostic Test: Lung Ultrasound | |
| Interstitial lung diseases (ILDs) | Interstitial lung diseases will be further classified using FVC% classes, categorized as mild, moderate, and severe. Receives: Diagnostic Test: Lung Ultrasound | |
| Bronchiectasis | patients with non-cystic fibrosis bronchiectasis Receives: Diagnostic Test: Lung Ultrasound | |
| Pleural Effusion | Patients with pleural effusion Receives: Diagnostic Test: Lung Ultrasound | |
| Pulmonary Oedema | Patient with any degree of Pulmonary oedema Receives: Diagnostic Test: Lung Ultrasound | |
| Control | Healthy control subjects for comparison Receives: Diagnostic Test: Lung Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Discriminative performance of LSI (total score, 0-36) between disease groups
The primary outcome is establishing a pattern of LSI among the seven studied groups
Measured: At Baseline
Secondary outcomes (1)
Correlation of LSI with clinical severity indices
Correlation of LSI with clinical severity indices (PaO₂/FiO₂ ratio, FVC %, mMRC, 6MWT)
Measured: At Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2025
- Study start30 May 2025
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Collaborators
- Aliae AR Mohamed Hussein [ahussein
- Responsible party
- Principal investigator, Ahmad Shaddad, Assiut University
- Investigators
- Ahmad M. Shaddad, MD, Principal investigator, Assiut UniversityAliae A. Hussien, MD, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06983366
- Sponsor's protocol ID
- IRBAU3211-2025
- Status last verified
- Sep 2026
- First submitted
- 6 May 2025
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: the decision regarding sharing individual participant data is under review and will be updated when determined
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation and Clinical Utility of the Lung Sliding Index (LSI) for Differentiating Pulmonary Diseases: A Prospective Case-Control Study
- ClinicalTrials.gov ID
- NCT06983366
- Acronym / sponsor ID
- IRBAU3211-2025
- Conditions
- COPD, ILD, Bronchiectasis, Pneumothorax, Pneumonia, Pleural Effusion Disorder
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Collaborators
- Aliae AR Mohamed Hussein [ahussein
- Study start
- 30 May 2025 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 21 May 2025 (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.
This upcoming case-control study aims to confirm the Lung Sliding Index (LSI), a new ultrasound score that measures how well the pleura moves, in various lung diseases. The study will check how well the LSI can tell apart different lung diseases (like pneumothorax, interstitial lung disease, COPD, pneumonia, and pulmonary edema), how it relates to signs of disease severity, and how consistent the results are between different operators who have received the same training. Secondary objectives include assessing patient and operator satisfaction and feasibility using validated Likert scales.
Detailed description
- The study will enroll adults with various pulmonary pathologies and healthy controls. Lung ultrasound will be performed on all subjects using a standardized 12-zone protocol; each zone will be scored for pleural sliding using the LSI (0-3 per zone; total 0-36). Operator training and calibration will precede enrollment to ensure scoring consistency.
- A subset of patients will undergo repeat assessments to evaluate intra- and interobserver reliability, using independent, blinded raters.
- For correlation with LSI, we will collect clinical data, including spirometry, blood gases, symptom scores, and 6-minute walk tests. Diagnostic utility will be evaluated using ROC curves. Satisfaction and feasibility will be assessed via Likert questionnaires, with validation analyses (internal consistency, test-retest reliability).
- All data will be de-identified and securely stored. Written informed consent will be obtained from all participants.
- The study groups will include: 1- Pneumothorax 2. Interstitial lung disease (ILD/IPF) 3. COPD/emphysema 4. Bronchiectasis 5. Community-acquired pneumonia 6. Pulmonary edema 7- Pleural effusion 8. Healthy controls
- Data Collection Methods:
- Standardized data entry forms for clinical, imaging, and outcome data.
- Centralized digital storage with access limited to study personnel.
Statistical Methods:
- Descriptive statistics for baseline data ANOVA or Kruskal-Wallis for group comparisons; post hoc testing as appropriate ROC analysis for diagnostic cut-offs Pearson/Spearman correlation for clinical associations Intraclass correlation coefficients (ICC) for reliability Cronbach's alpha for Likert scale validation Multivariable regression for confounder adjustment
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Chronic obstructive pulmonary disease (COPD) | – | Diagnostic Test: Lung UltrasoundChronic obstructive pulmonary disease patients will be further classified as mild, moderate, severe, and very severe according to GOLD classification. |
| Pneumothorax | – | Diagnostic Test: Lung UltrasoundPatients with Pneumothorax |
| Community-acquired pneumonia (CAP) | – | Diagnostic Test: Lung UltrasoundCommunity-acquired pneumonia will be classified using the CURB-65 score into mild, moderate, and severe. |
| Interstitial lung diseases (ILDs) | – | Diagnostic Test: Lung UltrasoundInterstitial lung diseases will be further classified using FVC% classes, categorized as mild, moderate, and severe. |
| Bronchiectasis | – | Diagnostic Test: Lung Ultrasoundpatients with non-cystic fibrosis bronchiectasis |
| Pleural Effusion | – | Diagnostic Test: Lung UltrasoundPatients with pleural effusion |
| Pulmonary Oedema | – | Diagnostic Test: Lung UltrasoundPatient with any degree of Pulmonary oedema |
| Control | – | Diagnostic Test: Lung UltrasoundHealthy control subjects for comparison |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients (>18 years) with: * Pneumothorax * Interstitial lung disease (ILD/IPF) * COPD/emphysema * Bronchiectasis * Community-acquired pneumonia * Pulmonary edema * Pleural effusion * Healthy controls
Key inclusion criteria (3 listed)
- Age 18 years and older.
- Diagnosed with one of the specified pulmonary diseases, or a healthy control
- Able to provide written informed consent
Key exclusion criteria (5 listed)
- Inability to tolerate or undergo a lung ultrasound
- Extensive chest wall pathology precluding assessment
- Unscorable >2 zones per protocol
- Withdrawal of consent
- Mechanically-ventilated patients
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 |
|---|---|---|
| Lung UltrasoundAll enrolled patient will be subjected to Lung Ultrasound examination LUS | Diagnostic test | Bronchiectasis, Chronic obstructive pulmonary disease (COPD), Community-acquired pneumonia (CAP), Control, Interstitial lung diseases (ILDs), Pleural Effusion, Pneumothorax, Pulmonary Oedema |
Primary outcome
Discriminative performance of LSI (total score, 0-36) between disease groups
Time frame: At Baseline
The primary outcome is establishing a pattern of LSI among the seven studied groups
1 secondary outcome
Correlation of LSI with clinical severity indices
Time frame: At Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Individual participant dataSharing planned: Undecided. the decision regarding sharing individual participant data is under review and will be updated when determined
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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.
Ahmad M. Shaddad, MD principal investigator
Assiut University
Aliae A. Hussien, MD principal investigator
Assiut University
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 COPD and ILD, run by Assiut 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 3 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 22 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ahmad M. Shaddad, MD (+201111171930, shaddad_ahmad@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Discriminative performance of LSI (total score, 0-36) between disease groups (time frame: At Baseline). 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 22 Sep 2026.