ClinicalTrials.gg
RecruitingNCT06983366Updated Sep 22, 2026

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

An observational study in COPD, ILD and Bronchiectasis, sponsored by Assiut University. Recruiting at 1 site in Egypt. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-22.

Sponsored by Assiut University · Observational

From the registry’s dates

  • Started May 2025; still recruiting 1 year 5 months later.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
700
Ages
18 Years and older
Sex
All
01

Study 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.

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

02

Conditions studied

  • COPD
  • ILD
  • Bronchiectasis
  • Pneumothorax
  • Pneumonia
  • Pleural Effusion Disorder
  • Pulmonary Oedema
03

In context

Pulmonary Disease, Chronic Obstructive

5,520 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 856 are open to participants now.

This study's planned enrollment of 700 is above the median of 158 across 1,497 observational studies indexed under Pulmonary Disease, Chronic Obstructive.

Browse Pulmonary Disease, Chronic Obstructive studies →

Lead sponsor

Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
700 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • Diagnostic testLung Ultrasound

    All enrolled patient will be subjected to Lung Ultrasound examination LUS

06

What researchers measure

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

    Time frame: 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)

    Time frame: At Baseline

07

Study locations

1 of 1 sites recruiting
  • Assiut University- Faculty of Medicine
    Asyut, 71515, Egypt
    Recruiting
    • Ahmad M. Shaddad, MD · ContactShaddad_ahmad@aun.edu.eg · +201111171939
    • Ahmad M. Shaddad, MD · Principal investigator
    • Aliae A Hussein, MD · Principal investigator
    • Maiada K Haahem, MD · Principal investigator
08

References and documents

Individual participant data

Plan to share: Undecided — the decision regarding sharing individual participant data is under review and will be updated when determined

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06983366
Lead sponsor
Assiut University
Collaborators
Aliae AR Mohamed Hussein [ahussein
Responsible party
Ahmad Shaddad (Associate professor of pulmonary medicine - faculty of medicine - Assuit University, Assiut University) — Principal investigator
First posted
May 21, 2025
Start date
May 30, 2025
Primary completion
Nov 1, 2026 (estimated)
Completion
Dec 1, 2026 (estimated)
Last update
Sep 22, 2026

Study contacts

Ahmad M. Shaddad, MD
Contact
shaddad_ahmad@yahoo.com
+201111171930
Ahmad M. Shaddad, MD
principal investigator · Assiut University
Aliae A. Hussien, MD
principal investigator · Assiut University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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