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

NCT06983366 | Recruiting

• 1 other identifier: IRBAU3211-2025
• Study Type: observational
• Target: 700
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

  At Baseline

Secondary Outcomes (1)

• Correlation of LSI with clinical severity indices

  At Baseline

Study Arms (8)

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.

Diagnostic Test: Lung Ultrasound

Pneumothorax

Patients with Pneumothorax

Diagnostic Test: Lung Ultrasound

Community-acquired pneumonia (CAP)

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

Diagnostic Test: Lung Ultrasound

Interstitial lung diseases (ILDs)

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

Diagnostic Test: Lung Ultrasound

Bronchiectasis

patients with non-cystic fibrosis bronchiectasis

Diagnostic Test: Lung Ultrasound

Pleural Effusion

Patients with pleural effusion

Diagnostic Test: Lung Ultrasound

Pulmonary Oedema

Patient with any degree of Pulmonary oedema

Diagnostic Test: Lung Ultrasound

Control

Healthy control subjects for comparison

Diagnostic Test: Lung Ultrasound

Interventions

Lung Ultrasound DIAGNOSTIC_TEST

All enrolled patient will be subjected to Lung Ultrasound examination LUS

Bronchiectasis; Chronic obstructive pulmonary disease (COPD); Community-acquired pneumonia (CAP); Control; Interstitial lung diseases (ILDs); Pleural Effusion; Pneumothorax; Pulmonary Oedema

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• Age 18 years and older.
• Diagnosed with one of the specified pulmonary diseases, or a healthy control
• Able to provide written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead
• Aliae AR Mohamed Hussein [ahussein: collaborator

Study Sites (1)

Assiut University- Faculty of Medicine

Asyut, 71515, Egypt

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Bronchiectasis; Pneumothorax; Pneumonia; Pleural Effusion; Pulmonary Edema

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bronchial Diseases; Pleural Diseases; Respiratory Tract Infections; Infections

Study Officials

• Ahmad M. Shaddad, MD

  Assiut University

  PRINCIPAL INVESTIGATOR

• Aliae A. Hussien, MD

  Assiut University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmad M. Shaddad, MD

CONTACT

+201111171930; shaddad_ahmad@yahoo.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor of pulmonary medicine - faculty of medicine - Assuit University

Study Record Dates

• First Submitted: May 6, 2025
• First Posted: May 21, 2025
• Study Start: May 30, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: April 30, 2026

Record last verified: 2026-04

Locations

EG (1)