Validation and Clinical Utility of the Lung Sliding Index (LSI) for Differentiating Pulmonary Diseases: A Prospective Case-Control Study
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
- 是
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
Ahmad Shaddad
Associate professor of pulmonary medicine - faculty of medicine - Assuit University
Assiut University
