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
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