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Validation and Clinical Utility of the Lung Sliding Index (LSI) for Differentiating Pulmonary Diseases

NCT06983366 · Assiut University
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Official title
Validation and Clinical Utility of the Lung Sliding Index (LSI) for Differentiating Pulmonary Diseases: A Prospective Case-Control Study
About this study
* 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
Eligibility criteria
Inclusion Criteria: * Age 18 years and older. * Diagnosed with one of the specified pulmonary diseases, or a healthy control * Able to provide written informed consent Exclusion Criteria: * 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
Study design
Enrollment target: 700 participants
Age groups: adult, older_adult
Timeline
Starts: 2025-05-30
Estimated completion: 2026-08-01
Last updated: 2026-04-30
Interventions
Diagnostic Test: Lung Ultrasound
Primary outcomes
  • Discriminative performance of LSI (total score, 0-36) between disease groups (At Baseline)
Sponsor
Assiut University · other
With: Aliae AR Mohamed Hussein [ahussein
Contacts & investigators
ContactAhmad M. Shaddad, MD · contact · shaddad_ahmad@yahoo.com · +201111171930
InvestigatorAhmad M. Shaddad, MD · principal_investigator, Assiut University
InvestigatorAliae A. Hussien, MD · principal_investigator, Assiut University
All locations (1)
Assiut University- Faculty of MedicineRecruiting
Asyut, Egypt
Validation and Clinical Utility of the Lung Sliding Index (LSI) for Differentiating Pulmonary Diseases · TrialPath