Evaluating lung ventilation patterns in patients with normal lung function
Pulmonary Ventilation Heterogeneity Determined by Electrical Impedance Tomography During Pulmonary Function Testing in Subjects With Normal One-second Rates
Sir Run Run Shaw Hospital · NCT06407986
This study is testing how air moves in the lungs of people with normal lung function to help improve early detection and treatment of breathing problems.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Sir Run Run Shaw Hospital (other) |
| Drugs / interventions | radiation |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT06407986 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the demographic characteristics of individuals with normal one-second forced expiratory rates undergoing pulmonary function tests. It will utilize Electrical Impedance Tomography (EIT) to identify spatial and temporal heterogeneity in lung ventilation among these patients. The study seeks to analyze the distribution patterns of lung ventilation, providing valuable insights for early screening, diagnosis, treatment monitoring, and prognostic evaluation of conditions like Preserved Ratio Impaired Spirometry (PRISm).
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who are undergoing lung function tests as recommended by their outpatient physicians.
Not a fit: Patients with a history of lung diseases other than COPD or those who cannot undergo EIT due to medical devices like pacemakers may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance early detection and management of lung function impairments in patients who currently appear to have normal lung function.
How similar studies have performed: While the use of EIT in lung ventilation assessment is emerging, this specific approach to studying PRISm in patients with normal lung function is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Age ≥18 years old. Patients who need to complete lung function tests assessed by outpatient physicians. Patients willing to participate in the study and sign an informed consent form. Exclusion Criteria: Patients with FEV1/FVC less than 0.7 after a bronchiectasis test. Patients with a history of lung diseases other than COPD, previous lung surgery, or radiation therapy. Patients who cannot be evaluated for EIT or who interfere with EIT results, such as implanted pacemakers/cardioverters. Patients who cannot complete EIT or may interfere with EIT results, such as those with implanted pacemakers/defibrillators. Patients who cannot complete lung function tests, such as myocardial infarction or shock in the past 3 months; severe heart failure or angina in the past 4 weeks，uncontrolled hypertension (systolic \>200mmHg, diastolic \>100mmHg)，severe hyperthyroidism etc. Vulnerable populations, including patients with mental illnesses, cognitive impairments, critically ill patients, illiterate, pregnant women, etc.
Where this trial is running
Hangzhou, Zhejiang
- Sir Run Run Shaw Hospital — Hangzhou, Zhejiang, China (RECRUITING)
Study contacts
- Study coordinator: Jiayi Li
- Email: 22218299@zju.edu.cn
- Phone: 17326082419
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Lung Function Decreased