Evaluating lung ventilation in patients with preserved ratio impaired spirometry using EIT
Heterogeneity of Lung Ventilation Determined by Electrical Impedance Tomography During Pulmonary Function Testing in Patients With Preserved Ratio Impaired Spirometry
This study is testing how well a new imaging technique can show lung ventilation patterns in people with preserved ratio impaired spirometry to help with early diagnosis and treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Sir Run Run Shaw Hospital Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT06199258 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the demographic characteristics of patients with Preserved Ratio Impaired Spirometry (PRISm) during pulmonary function tests. It investigates the use of Electrical Impedance Tomography (EIT) to identify spatial and temporal heterogeneity of lung ventilation in these individuals. The study seeks to analyze the distribution patterns of lung ventilation to provide evidence for early screening, diagnosis, treatment monitoring, and prognostic evaluation of PRISm. By focusing on this population, the study addresses a significant gap in current diagnostic and treatment guidelines.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who require 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 may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved early detection and management strategies for patients with PRISm, potentially reducing the risk of developing COPD.
How similar studies have performed: While the use of EIT in lung ventilation assessment is emerging, this specific approach to PRISm 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 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.