Comparison of Lung Ultrasound Findings, Functional Capacity, and Dyspnea Between Patients With Acute Exacerbation and Stable Chronic Obstructive Pulmonary Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 85
- 试验地点
- 1
- 主要终点
- Lung Ultrasound Score
研究概览
简要总结
This cross-sectional study aims to compare lung ultrasound findings, functional capacity, and dyspnea among patients with acute exacerbation of chronic obstructive pulmonary disease (AECOPD), patients with stable COPD, and healthy controls. The study will include approximately 60 participants divided into three groups (acute exacerbation COPD, stable COPD, and healthy controls). Participants will undergo comprehensive assessments including lung ultrasound, pulmonary function tests, the Modified Borg Scale, the Modified Medical Research Council (mMRC) Dyspnea Scale, the 6-Minute Walk Test, the 1-Minute Sit-to-Stand Test, the COPD Assessment Test (CAT), the Charlson Comorbidity Index, and the BODE Index. The primary objective is to determine differences in lung ultrasound abnormalities, particularly B-lines, consolidations, and lung ultrasound scores, and to investigate their relationship with functional capacity and dyspnea severity. The findings are expected to clarify the clinical utility of lung ultrasound as a non-invasive bedside assessment tool for evaluating disease severity and supporting comprehensive management of patients with COPD.
详细描述
Chronic obstructive pulmonary disease (COPD) is a progressive respiratory disease characterized by persistent airflow limitation, chronic respiratory symptoms, and recurrent exacerbations that contribute to substantial morbidity, mortality, and healthcare utilization. Acute exacerbations accelerate disease progression, impair functional capacity, increase dyspnea severity, and worsen quality of life. Early identification of pulmonary abnormalities during exacerbation is therefore essential for optimizing clinical management and improving patient outcomes.
Lung ultrasound (LUS) has emerged as a non-invasive, radiation-free, bedside imaging modality that enables rapid assessment of pulmonary pathology. LUS can identify clinically relevant findings such as B-lines, consolidations, pleural abnormalities, and pleural effusions, making it a valuable complementary tool in the evaluation of respiratory diseases. Because it is portable, repeatable, and safe, LUS is increasingly incorporated into the assessment and monitoring of patients with chronic respiratory disorders, including COPD. Despite these advantages, evidence regarding the role of lung ultrasound in distinguishing acute exacerbation from stable COPD and its relationship with clinical outcomes remains limited.
The present study is designed as a cross-sectional comparative study involving three groups: patients with acute exacerbation of COPD, patients with stable COPD, and healthy individuals. Approximately 60 participants will be recruited and undergo standardized assessments. Lung ultrasound will be performed using a 12-zone protocol to evaluate B-line distribution, A-line dominance, lung ultrasound score, consolidations, pleural effusion, and other sonographic abnormalities. Functional status and symptom burden will be assessed using the 6-Minute Walk Test (6MWT), 1-Minute Sit-to-Stand Test (1STS), Modified Borg Dyspnea Scale, modified Medical Research Council (mMRC) Dyspnea Scale, COPD Assessment Test (CAT), Charlson Comorbidity Index, BODE Index, and spirometry.
The primary objective of this study is to compare lung ultrasound findings, functional capacity, and dyspnea among patients with acute exacerbation COPD, stable COPD, and healthy controls. Additionally, the study aims to determine whether lung ultrasound findings are associated with functional impairment and symptom severity. The results are expected to provide evidence supporting the clinical utility of lung ultrasound as a rapid and comprehensive assessment tool that complements conventional clinical evaluation in COPD and contributes to multidisciplinary management strategies.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Acute Exacerbation COPD Group
- •Adults aged 40-65 years.
- •Diagnosis of chronic obstructive pulmonary disease (COPD) according to GOLD criteria.
- •Currently experiencing an acute exacerbation of COPD.
- •Able and willing to provide written informed consent.
- •Stable COPD Group
- •Adults aged 40-75 years.
- •Diagnosis of chronic obstructive pulmonary disease (COPD) according to GOLD criteria.
- •Clinically stable without an acute exacerbation at the time of assessment.
- •Able and willing to provide written informed consent.
- •Healthy Control Group
- •Adults aged 40-65 years.
- •No history of chronic pulmonary disease.
- •Able and willing to provide written informed consent.
排除标准
- •Presence of cardiovascular, neurological, orthopedic, psychiatric, or other systemic diseases that may affect study assessments.
- •Cognitive impairment or psychological conditions preventing completion of study procedures.
- •History of thoracic or major surgery that could influence pulmonary function or lung ultrasound findings.
- •Pregnancy.
- •Inability to perform pulmonary function testing or functional exercise tests.
- •Refusal or inability to provide written informed consent.
研究组 & 干预措施
Acute Exacerbation COPD
Patients diagnosed with chronic obstructive pulmonary disease (COPD) who are experiencing an acute exacerbation. Participants will undergo lung ultrasound, pulmonary function testing, functional capacity assessment (6-Minute Walk Test and 1-Minute Sit-to-Stand Test), dyspnea evaluation (Modified Borg Scale and mMRC Dyspnea Scale), COPD Assessment Test (CAT), Charlson Comorbidity Index, and BODE Index.
Stable COPD
Patients with clinically stable chronic obstructive pulmonary disease (COPD) without an acute exacerbation. Participants will undergo the same assessments as the acute exacerbation group, including lung ultrasound, pulmonary function testing, functional capacity tests, dyspnea evaluation, CAT, Charlson Comorbidity Index, and BODE Index.
Healthy Controls
Age-matched healthy individuals without chronic pulmonary disease or other significant cardiopulmonary, neurological, orthopedic, or psychiatric disorders. Participants will undergo lung ultrasound, pulmonary function testing, functional capacity assessment, and dyspnea evaluation using the same standardized procedures as the COPD groups.
结局指标
主要结局
Lung Ultrasound Score
时间窗: Baseline (Cross-sectional assessment)
Total lung ultrasound score (0-36) obtained using a standardized 12-zone lung ultrasound protocol. The score reflects the degree of lung aeration loss based on the presence of A-lines, B-lines, confluent B-lines, and consolidations.
次要结局
- Six-Minute Walk Distance (6MWD)(Baseline)
- One-Minute Sit-to-Stand Test(Baseline)
- Modified Borg Dyspnea Scale(Baseline)
- Modified Medical Research Council (mMRC) Dyspnea Scale(Baseline)
- COPD Assessment Test (CAT)(Baseline)
- Peak Expiratory Flow (PEF)(Baseline)
- BODE Index(Baseline)
- Charlson Comorbidity Index(Baseline)
- Depression Anxiety Stress Scale-21 - Depression Subscale(Baseline)
- Depression Anxiety Stress Scale-21 - Stress Subscale(Baseline)
- Depression Anxiety Stress Scale-21 - Anxiety Subscale(Baseline)
- Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS-A)(Baseline)
- Hospital Anxiety and Depression Scale - Depression Subscale (HADS-D)(Baseline)
- Forced Expiratory Volume in One Second (FEV1)(Baseline)
- Forced Vital Capacity (FVC)(Baseline)
- Forced Expiratory Flow at 25-75% of Forced Vital Capacity (FEF25-75%)(Baseline)