COPDNCT06199258
Heterogeneity of Lung Ventilation Determined by EIT During PFT in Patients With PRISM
An observational study of COPD, run by Sir Run Run Shaw Hospital at 1 site in China.
Trial summary
To evaluate the demographic characteristics of PRISm 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 PRISm during pulmonary function testing. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- COPD
- What is being tested?
- pulmonary function test
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 5 Dec 2023to 1 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Gender, age, height, weight, smoking history, reason for seeking medical care, medication history, history of oxygen therapy, comorbidities.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sir Run Run Shaw Hospital
Hangzhou, Zhejiang, 310000
Jiayi Li, 17326082419, 22218299@zju.edu.cn
About this study
Official title: Heterogeneity of Lung Ventilation Determined by Electrical Impedance Tomography During Pulmonary Function Testing in Patients With Preserved Ratio Impaired Spirometry
To evaluate the demographic characteristics of PRISm 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 PRISm during pulmonary function testing.
To investigate the distribution patterns of lung ventilation in individuals with PRISm using this technique, and provide references and evidence for early screening, diagnosis, treatment monitoring, and prognostic evaluation.
Read the 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 (FEV1)/forced vital capacity (FVC) ratio (FEV1/FVC≥0.7, after bronchodilator use), but exhibit impaired pulmonary ventilation function with FEV1 and/or 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. 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.
- Conditions
- COPD
- Being tested
- pulmonary function test
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pulmonary function testDiagnostic test
pulmonary function testing
| Study group | Role | What they receive |
|---|---|---|
| Normal lung function | Normal lung function: After using a bronchodilator, FEV1/FVC ≥70%, FEV1 and FVC ≥80% of reference values. Receives: Diagnostic Test: pulmonary function test | |
| Preserved ratio impaired spirometry | After using a bronchodilator, FEV1/FVC≥70%, FEV1 and/or FVC<80% of reference values. Receives: Diagnostic Test: pulmonary function test | |
| Chronic obstructive pulmonary disease | After using a bronchodilator, FEV1/FVC <70%. Receives: Diagnostic Test: pulmonary function test |
What is being measured
The primary outcome is the main question the study is designed to answer.
GI
EIT parameters
Measured: one month
time constant time constant in second
EIT parameters
Measured: one month
abnormal area in percent time constant in second
EIT parameters
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2024
- Study start5 Dec 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion1 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sir Run Run Shaw Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Huiqing Ge, Study chair, Sir Run Run Shaw Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06199258
- Sponsor's protocol ID
- 2023-933-01
- Status last verified
- May 2024
- First submitted
- 27 Dec 2023
- Last updated
- 8 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heterogeneity of Lung Ventilation Determined by Electrical Impedance Tomography During Pulmonary Function Testing in Patients With Preserved Ratio Impaired Spirometry
- ClinicalTrials.gov ID
- NCT06199258
- Acronym / sponsor ID
- 2023-933-01
- Conditions
- COPD
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Sir Run Run Shaw HospitalUniversity, hospital or other
- Study start
- 5 Dec 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 10 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the demographic characteristics of PRISm 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 PRISm during pulmonary function testing.
To investigate the distribution patterns of lung ventilation in individuals with PRISm 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 (FEV1)/forced vital capacity (FVC) ratio (FEV1/FVC≥0.7, after bronchodilator use), but exhibit impaired pulmonary ventilation function with FEV1 and/or 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. 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Normal lung function | – | Diagnostic Test: pulmonary function testNormal lung function: After using a bronchodilator, FEV1/FVC ≥70%, FEV1 and FVC ≥80% of reference values. |
| Preserved ratio impaired spirometry | – | Diagnostic Test: pulmonary function testAfter using a bronchodilator, FEV1/FVC≥70%, FEV1 and/or FVC<80% of reference values. |
| Chronic obstructive pulmonary disease | – | Diagnostic Test: pulmonary function testAfter using a bronchodilator, FEV1/FVC <70%. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Gender, age, height, weight, smoking history, reason for seeking medical care, medication history, history of oxygen therapy, comorbidities.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pulmonary function testpulmonary function testing | Diagnostic test | Chronic obstructive pulmonary disease, Normal lung function, Preserved ratio impaired spirometry |
Primary outcome
GI
Time frame: one month
EIT parameters
time constant time constant in second
Time frame: one month
EIT parameters
abnormal area in percent time constant in second
Time frame: one month
EIT parameters
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Huiqing Ge study chair
Sir Run Run Shaw Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD, run by Sir Run Run Shaw Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jiayi Li (17326082419, 22218299@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GI (time frame: one month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2024.