Skip to content

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

Validation and Clinical Utility of the Lung Sliding Index (LSI) for Differentiating Pulmonary Diseases: A Prospective Case-Control Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06983366
Enrollment
700
Registered
2025-05-21
Start date
2025-05-30
Completion date
2026-08-01
Last updated
2026-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bronchiectasis, COPD, ILD, Pleural Effusion Disorder, Pneumonia, Pneumothorax, Pulmonary Oedema

Brief 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 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

Interventions

DIAGNOSTIC_TESTLung Ultrasound

All enrolled patient will be subjected to Lung Ultrasound examination LUS

Sponsors

Assiut University
Lead SponsorOTHER
Aliae AR Mohamed Hussein [ahussein
CollaboratorUNKNOWN

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Discriminative performance of LSI (total score, 0-36) between disease groupsAt BaselineThe primary outcome is establishing a pattern of LSI among the seven studied groups

Secondary

MeasureTime frameDescription
Correlation of LSI with clinical severity indicesAt BaselineCorrelation of LSI with clinical severity indices (PaO₂/FiO₂ ratio, FVC %, mMRC, 6MWT)

Countries

Egypt

Contacts

CONTACTAhmad M. Shaddad, MD
shaddad_ahmad@yahoo.com+201111171930
PRINCIPAL_INVESTIGATORAhmad M. Shaddad, MD

Assiut University

PRINCIPAL_INVESTIGATORAliae A. Hussien, MD

Assiut University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 1, 2026