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

Assiut University

Status: Enrolling

Conditions: Pneumothorax; Bronchiectasis; Pneumonia; COPD; Pulmonary Oedema; ILD; Pleural Effusion Disorder

Treatments: Diagnostic Test: Lung Ultrasound

Study type: Observational

Funder types: Other

Identifiers

NCT06983366

IRBAU3211-2025

Details and patient eligibility

About

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.

Full 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

Enrollment: 700 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

700 participants in 8 patient groups

COPD

Description:

Chronic obstructive pulmonary disease patients will be further classified as mild, moderate, severe, and very severe according to GOLD classification.

Treatment:

Diagnostic Test: Lung Ultrasound

Pneumothorax

Description:

Patients with Pneumothorax

Treatment:

Diagnostic Test: Lung Ultrasound

CAP

Description:

Community-acquired pneumonia will be classified using the CURB-65 score into mild, moderate, and severe.

Treatment:

Diagnostic Test: Lung Ultrasound

ILDs

Description:

Interstitial lung diseases will be further classified using FVC% classes, categorized as mild, moderate, and severe.

Treatment:

Diagnostic Test: Lung Ultrasound

Bronchiectasis

Description:

patients with non-cystic fibrosis bronchiectasis

Treatment:

Diagnostic Test: Lung Ultrasound

Pleural Effusion

Description:

Patients with pleural effusion

Treatment:

Diagnostic Test: Lung Ultrasound

Pulmonary Oedema

Description:

Patient with any degree of Pulmonary oedema

Treatment:

Diagnostic Test: Lung Ultrasound

Control

Description:

Healthy control subjects for comparison

Treatment:

Diagnostic Test: Lung Ultrasound