Exploring the Diagnostic Performance of Dynamic Chest Radiology in Chronic Obstructive Pulmonary Disease

NCT06653413 | Recruiting

• 2 other identifiers: NFEC-2024-15832470763
• Study Type: observational
• Target: 2,500
• Locations: 1 country
• Sites: 1

Brief Summary

The prevalence of chronic obstructive pulmonary disease (COPD) is on the rise, leading to an increasing economic and social burden. Currently, the diagnosis and staging of COPD heavily rely on pulmonary function testing. However, limitations such as patient cooperation and comorbidities can hinder accurate diagnosis. In situations like a respiratory pandemic, pulmonary function testing may not be feasible. Dynamic chest radiography has emerged as a promising area of research due to its quick procedure, high patient cooperation, low risk, minimal radiation exposure, and reduced direct contact. Recent clinical studies have started to explore the relationship between dynamic chest X-ray measurements and lung function parameters. However, there is a noticeable scarcity of research focusing on the use of dynamic chest X-ray in aiding the diagnosis of COPD, particularly in Chinese populations where cohort data is lacking. Consequently, there is a pressing need to investigate the correlation between various dynamic chest radiograph parameters and lung function indicators, as well as their potential diagnostic value in COPD.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

Chronic obstructive pulmonary disease; Dynamic chest radiology; Pulmonary function test; Diagnosis

Outcome Measures

Primary Outcomes (1)

• Dynamic chest radiographs were used to measure diaphragm movement, lung field area and lung field area change rate

  Dynamic chest radiographs of patients with COPD were analyzed and their correlation with lung function was studied. To study the value of dynamic chest radiography in diagnosing COPD. To investigate the role of dynamic chest radiography in evaluating the severity of airflow restriction in COPD and predicting the clinical outcome of COPD.

  3 year

Study Arms (2)

COPD group

any patient who complains of dyspnea, chronic cough or sputum, a history of recurrent lower respiratory infection and/or a history of exposure to disease risk factors, Pulmonary function examination indicated that FEV1/FVC \<0.7 after bronchodilator was used to confirm COPD.

normal group

No acute or chronic cardiopulmonary disease in the past, no abnormal lung physical examination and lung imaging examination in the past month, no history of infectious diseases.

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This is a prospective clinical study of COPD patients and normal subjects in our hospital. This study has been approved by the hospital Ethics Committee and the patient's informed consent has been obtained (approval number: MR-44-24-016286).

You may qualify if:

• \- COPD group: (1) Patients ≥30 years of age and ≤ 80 years of age who meet the 2023 GOLD Guidelines for the Diagnosis and Treatment of Chronic Obstructive Pulmonary Disease, i.e., anyone who complains of dyspnea, chronic cough or sputum, a history of recurrent lower respiratory infection and/or exposure to disease risk factors, Moreover, pulmonary function examination indicated that FEV1/FVC \<0.7 after bronchodilator was used to confirm COPD. FEV1%pred is used to determine the severity of airflow obstruction: Grade GOLD 1 (mild) : FEV1%pred ≥ 80%, Grade GOLD2 (moderate) : 50% ≤ FEV1%pred \< 80%, grade GOLD3 (severe) : 30% ≤ FEV1%pred \< 50%, GOLD4 grade (extremely severe) : FEV1%pred \< 30%; (2) Signing informed consent; (3) Can cooperate with the completion of dynamic chest X-ray (complete dynamic chest X-ray positioning for 20 seconds, during which calm breathing, hard breathing, can hold breath for at least 7 seconds).
• Normal Group: (1) Age ≥30 years old and ≤ 80 years old; (2) Normal pulmonary ventilation function; (3) Exclude chronic airway diseases (such as COPD, asthma, bronchiectasis, etc.); (4) Signing informed consent; (5) Can cooperate with the completion of dynamic chest X-ray (complete dynamic chest X-ray positioning for 20 seconds, during which calm breathing, hard breathing, can hold breath for at least 7 seconds).

You may not qualify if:

• COPD group: (1) A history of cancer, lung surgery, other lung diseases (such as pneumonia, active tuberculosis, severe bronchiectasis); (2) Combined with muscle-related diseases such as myasthenia gravis or wasting diseases that affect muscle mass such as severe hyperthyroidism and advanced malignant diseases; (3) Pregnant or lactating women; (4) Significant radiation exposure (dose \>10mSv) was involved in the 12 months prior to study participation. Normal Group: (1) Have acute or chronic cardiopulmonary disease in the past, abnormal lung physical examination and lung imaging examination in the past, and have a history of infectious diseases within the past 1 month; (2) Pregnant or lactating women; (3) Significant radiation exposure (dose \>10mSv) was involved in the 12 months prior to study participation.

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead
• The First Affiliated Hospital of Guangzhou Medical University: collaborator
• Shenzhen People's Hospital: collaborator
• Qingyuan People's Hospital: collaborator

Study Sites (1)

Guangdong Locations

Guangzhou, Guangdong, China

RECRUITING

Related Publications (1)

• Yu D, Xie W, Guo Y, Zhu X, Liang W, Li M, Mao Y, He Z, Wu J, Yuan L, Huang W, Huang J, He S, Zhou Z, Huang X, Zhan Y, Dong H, Cai S, Cui ZK, Qin G, Liu L. Dynamic Chest Radiography as an Alternative to Pulmonary Function Tests for Chronic Obstructive Pulmonary Disease. Radiology. 2025 Dec;317(3):e251296. doi: 10.1148/radiol.251296.

  PMID: 41400467 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Laiyu Liu, professor

  Nanfang Hospital, Southern Medical University

  STUDY CHAIR

Central Study Contacts

Laiyu Liu, professor

CONTACT

+86 13632102245; liulaiyu@sina.com

Dong Yu, PhD student

CONTACT

+86 15625868995; 15625868995@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2024
• First Posted: October 22, 2024
• Study Start: January 1, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: July 20, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)