Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06407986
Status:
RECRUITING
Last Update Posted:
2024-05-30
First Post:
2024-05-06
Brief Title:
Pulmonary Ventilation Heterogeneity Determined by EIT During PFT in Subjects With Normal One-second Rates
Sponsor:
Sir Run Run Shaw Hospital
Organization:
Sir Run Run Shaw Hospital
Study Overview
Official Title:
Pulmonary Ventilation Heterogeneity Determined by Electrical Impedance Tomography During Pulmonary Function Testing in Subjects With Normal One-second Rates
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To evaluate the demographic characteristics of normal one-second rates population in patients with pulmonary function tests recommended by outpatient physicians
To investigate whether EIT can identify spatial and temporal heterogeneity of lung ventilation in individuals with normal one-second rates during pulmonary function testing
To investigate the distribution patterns of lung ventilation in individuals with normal one-second rates using this technique and provide references and evidence for early screening diagnosis treatment monitoring and prognostic evaluation
To investigate whether EIT can identify spatial and temporal heterogeneity of lung ventilation in individuals with normal one-second rates during pulmonary function testing
To investigate the distribution patterns of lung ventilation in individuals with normal one-second rates using this technique and provide references and evidence for early screening diagnosis treatment monitoring and prognostic evaluation
Detailed Description:
In the GOLD 2023 guidelines a newly introduced term called Preserved Ratio Impaired Spirometry PRISm refers to patients who have a normal forced expiratory volume in one second FEV1forced vital capacity FVC ratio FEV1FVC07 after bronchodilator use but exhibit impaired pulmonary ventilation function with FEV1 andor FVC values below 80 of the predicted value In the past these patients were often classified as GOLD U or restrictive ventilatory impairment In recent years several large cross-sectional and longitudinal studies on PRISm have revealed its high prevalence ranging from 5-20 due to population heterogeneity Notably approximately 10 to 40 of patients with PRISm tend to develop chronic obstructive pulmonary disease COPD resulting in frequent healthcare utilization Moreover subjects with normal lung function are also at risk of converting to PRISm during long-term follow-up Studies have found that such patients are associated with increased respiratory symptoms reduced quality of life and increased burden of cardiovascular disease A recent meta-analysis showed a significant increased risk of all-cause cardiovascular and respiratory-related mortality risk in PRISm patients Currently there are no diagnostic and treatment guidelines for PRISm but studies highlights the importance of screening and identifying PRISm with follow-up and early intervention if necessary
Electrical Impedance Tomography EIT is an emerging imaging technology developing rapidly in recent years with many advantages such as non-invasive non-radiation and simple operation Its principle is to measure the voltage or current signals through electrodes on the body surface and then reconstructing images of the distribution of impedance changes This technology is widely used in pulmonary diseases including monitoring lung ventilation distribution blood perfusion and titration of positive end-expiratory pressure EIT images have high spatial and temporal resolution can display physiological and pathological changes in real time based on breathing In 2022 China issued the clinical application consensus of electrical impedance tomography in critical respiratory management further promoting the application of this technology in respiratory management However the number of clinical studies on EIT in identifying airway obstruction in COPD patients is limited It has been proven that in COPD patients EIT combined with pulmonary function tests can evaluate the spatial and temporal distribution of lung capacity in different regions and identify pathologically induced ventilation heterogeneity At present the pathophysiological mechanism of PRISm is still under discussion Studies have found that PRISm is related to small airway dysfunction SAD and decreased total lung capacity Computed Tomography CT can be used to evaluate small airway function and observe the morphological and structural changes of lung tissue but it has but it has some disadvantages such as long duration and radiation exposure Therefore EIT may be a good choice for rapidly assessing regional lung function in PRISm patients Due to the scarcity of EIT in PRISm studies investigators have initiated a clinical study to evaluate whether ventilation heterogeneity in PRISm patients can be obtained through the combination of EIT and pulmonary function tests
Electrical Impedance Tomography EIT is an emerging imaging technology developing rapidly in recent years with many advantages such as non-invasive non-radiation and simple operation Its principle is to measure the voltage or current signals through electrodes on the body surface and then reconstructing images of the distribution of impedance changes This technology is widely used in pulmonary diseases including monitoring lung ventilation distribution blood perfusion and titration of positive end-expiratory pressure EIT images have high spatial and temporal resolution can display physiological and pathological changes in real time based on breathing In 2022 China issued the clinical application consensus of electrical impedance tomography in critical respiratory management further promoting the application of this technology in respiratory management However the number of clinical studies on EIT in identifying airway obstruction in COPD patients is limited It has been proven that in COPD patients EIT combined with pulmonary function tests can evaluate the spatial and temporal distribution of lung capacity in different regions and identify pathologically induced ventilation heterogeneity At present the pathophysiological mechanism of PRISm is still under discussion Studies have found that PRISm is related to small airway dysfunction SAD and decreased total lung capacity Computed Tomography CT can be used to evaluate small airway function and observe the morphological and structural changes of lung tissue but it has but it has some disadvantages such as long duration and radiation exposure Therefore EIT may be a good choice for rapidly assessing regional lung function in PRISm patients Due to the scarcity of EIT in PRISm studies investigators have initiated a clinical study to evaluate whether ventilation heterogeneity in PRISm patients can be obtained through the combination of EIT and pulmonary function tests
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None