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临床试验/NCT06983366
NCT06983366招募中不适用

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

Assiut University2 个研究点 分布在 1 个国家目标入组 700 人开始时间: 2025年5月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
700
试验地点
2
主要终点
Discriminative performance of LSI (total score, 0-36) between disease groups

研究概览

简要总结

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.

详细描述

  • 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

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

研究组 & 干预措施

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.

干预措施: Lung Ultrasound (Diagnostic Test)

Pneumothorax

Patients with Pneumothorax

干预措施: Lung Ultrasound (Diagnostic Test)

Community-acquired pneumonia (CAP)

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

干预措施: Lung Ultrasound (Diagnostic Test)

Interstitial lung diseases (ILDs)

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

干预措施: Lung Ultrasound (Diagnostic Test)

Bronchiectasis

patients with non-cystic fibrosis bronchiectasis

干预措施: Lung Ultrasound (Diagnostic Test)

Pleural Effusion

Patients with pleural effusion

干预措施: Lung Ultrasound (Diagnostic Test)

Pulmonary Oedema

Patient with any degree of Pulmonary oedema

干预措施: Lung Ultrasound (Diagnostic Test)

Control

Healthy control subjects for comparison

干预措施: Lung Ultrasound (Diagnostic Test)

结局指标

主要结局

Discriminative performance of LSI (total score, 0-36) between disease groups

时间窗: At Baseline

The primary outcome is establishing a pattern of LSI among the seven studied groups

次要结局

  • Correlation of LSI with clinical severity indices(At Baseline)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmad Shaddad

Associate professor of pulmonary medicine - faculty of medicine - Assuit University

Assiut University

研究点 (2)

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