Lung DiseasesNCT05346081
Pulmonary Function Assessment and Evaluation Using Self-administrable and Portable Electrical Impedance Tomography
An observational study of Lung Diseases, run by Queen Mary Hospital, Hong Kong at 1 site in Hong Kong.
Trial summary
Spirometry is the most commonly used modality for measuring lung function. However, spirometry is a coordination-dependent test and may lead to erroneous results if subjects are unable to fully comply with the instructions. It also lacks the capability for regional assessment of pulmonary functions. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lung Diseases
- What is being tested?
- Electrical impedance tomography
- Type of treatment
- Medical device
- How many people
- 125 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 May 2023to 30 Jun 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 75 years
- All sexes
- Adult, Older adult
Study population: Pulmonary disease subjects Patients of age 18 to 75 suspected or diagnosed with pulmonary diseases scheduled to undergo standard pulmonary function test will be recruited. These patients will undergo an interview (with a structured questionnaire), Pulmonary Functional Test (PFT) and EIT examination. Healthy control subjects Healthy adults of age 18 to 75 who do not have any known pulmonary diseases will be examined. These healthy individuals will undergo spirometry and EIT examination, as well as an interview with a structured questionnaire to ensure they do not have any clinical features or symptoms.
Who may be able to join
- Pulmonary disease subjects Patients of age 18 to 75 suspected or diagnosed with pulmonary diseases scheduled to undergo standard pulmonary function test will be recruited. These patients will undergo an interview (with a structured questionnaire), Pulmonary Functional Test (PFT) and EIT examination.
- Healthy control subjects Healthy adults of age 18 to 75 who do not have any known pulmonary diseases will be examined. These healthy individuals will undergo spirometry and EIT examination, as well as an interview with a structured questionnaire to ensure they do not have any clinical features or symptoms.
Who cannot join
- Subjects with implanted electronic devices, in case EIT might interfere with the devices
- Subjects with spinal diseases
- Subjects with unstable cardiac or respiratory conditions
- Pregnant women
- Patients who are unable to perform spirometry
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
Queen Mary Hospital
Hong Kong
Venus Li, 22553111, livenus@hku.hk
About this study
Spirometry is the most commonly used modality for measuring lung function. However, spirometry is a coordination-dependent test and may lead to erroneous results if subjects are unable to fully comply with the instructions. It also lacks the capability for regional assessment of pulmonary functions.
Electrical impedance tomography (EIT) is a potential alternative test to spirometry. EIT has been employed in clinical use to provide qualitative and quantitative measurements of ventilation in patients on mechanical ventilators to prevent lung damage or patient-ventilator desynchronies.
Read more
In this study, we aim to utilize EIT lung device to study EIT-derived indicators in pulmonary functional assessment and develop novel biomarkers for detecting and monitoring pulmonary diseases. This is a non-interventional clinical study on patients with chronic lung diseases, to establish the feasibility of using EIT-lung device in detecting lung functional changes. Specifically, we will establish the relationship between EIT-derived functional indicators and spirometry results. Furthermore, we will explore, develop, and establish EIT-derived regional lung functional indicators in healthy and chronic diseased states.
Subjects with underlying lung disease, and age- and gender-matched healthy control subjects will be recruited in this study. They will perform spirometry and EIT examination, as well as an interview with a structured questionnaire.
The results from spirometry and EIT test will be correlated and compared to identify the feasibility and accuracy of EIT lung device. Lung function parameters (e.g. FEV1, FVC, and FEV1/FVC ratio) measured using a spirometer would also be calculated from lung flow-volume curves derived from continuous EIT functional images. Regional lung function assessment will also be explored using EIT, and establish regional EIT features that could assist in screening and evaluating different chronic lung diseases. The EIT-derived indicators will be finally analyzed together with demographics, clinical assessments and patient history to derive fine grained insights and elucidate the effect of demographics and biometrics on EIT lung data. The parameters include, but not limited to, age, chest size, gender, weight, height, BMI, smoking habits and ethnicity. The analysis will improve the stability of the EIT indicators, and ultimately increase their predictive power towards diseased lung regions.
With the availability of the EIT device on lung function assessment, which was validated with spirometry findings, patients who are unable to perform spirometry but need a proper lung function assessment can benefit by having the EIT test. These patients include but not limited to those who need major lung resection and interstitial lung diseases on anti-fibrotic. EIT can also be a more comfortable alternative to spirometry for patients who need lung function assessment.
- Conditions
- Lung Diseases
- Being tested
- Electrical impedance tomography
- Medical subject headings
- Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrical impedance tomographyDevice
Electrical impedance tomography (EIT) is a potential alternative non-invasive diagnostic screening measure to spirometry.
| Study group | Role | What they receive |
|---|---|---|
| Patients with underlying lung disease | Not described Receives: Device: Electrical impedance tomography | |
| Healthy subjects | Not described Receives: Device: Electrical impedance tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional test comparison between spirometry and EIT lung device:
This study will elucidate the feasibility of EIT in testing lung function in patients and compare its outcomes with the spirometry tests. We expect that the global EIT-derived functional parameters corroborate with spirometry results.
Measured: 31/12/2022
Regional lung function assessment in patients
Regional EIT-derived structural and functional biomarkers of patients and healthy controls will be analyzed. This will potentially establish EIT-derived biomarkers for different chronic lung diseases.
Measured: 31/12/2022
Effect of demographics, clinical assessments and patient history on EIT measurements
EIT derived indicators will be finally analyzed together with demographics, clinical assessments (including CT scans if available) and patient history to derive fine grained insights for potential early detection and treatment monitoring of different chronic lung diseases.
Measured: 31/12/2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2022
- Study start1 May 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung DiseasesStudies 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
- Cross-sectional
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Queen Mary Hospital, Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kwok Wang Chun, Queen Mary Hospital, Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05346081
- Sponsor's protocol ID
- UW 21-644
- Status last verified
- Nov 2023
- First submitted
- 20 Apr 2022
- Last updated
- 18 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary Function Assessment and Evaluation Using Self-administrable and Portable Electrical Impedance Tomography
- ClinicalTrials.gov ID
- NCT05346081
- Acronym / sponsor ID
- UW 21-644
- Conditions
- Lung Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Queen Mary Hospital, Hong KongUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 26 Apr 2022 (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.
Spirometry is the most commonly used modality for measuring lung function. However, spirometry is a coordination-dependent test and may lead to erroneous results if subjects are unable to fully comply with the instructions. It also lacks the capability for regional assessment of pulmonary functions.
Electrical impedance tomography (EIT) is a potential alternative test to spirometry. EIT has been employed in clinical use to provide qualitative and quantitative measurements of ventilation in patients on mechanical ventilators to prevent lung damage or patient-ventilator desynchronies.
In this study, we aim to utilize EIT lung device to study EIT-derived indicators in pulmonary functional assessment and develop novel biomarkers for detecting and monitoring pulmonary diseases. This is a non-interventional clinical study on patients with chronic lung diseases, to establish the feasibility of using EIT-lung device in detecting lung functional changes. Specifically, we will establish the relationship between EIT-derived functional indicators and spirometry results. Furthermore, we will explore, develop, and establish EIT-derived regional lung functional indicators in healthy and chronic diseased states.
Subjects with underlying lung disease, and age- and gender-matched healthy control subjects will be recruited in this study. They will perform spirometry and EIT examination, as well as an interview with a structured questionnaire.
The results from spirometry and EIT test will be correlated and compared to identify the feasibility and accuracy of EIT lung device. Lung function parameters (e.g. FEV1, FVC, and FEV1/FVC ratio) measured using a spirometer would also be calculated from lung flow-volume curves derived from continuous EIT functional images. Regional lung function assessment will also be explored using EIT, and establish regional EIT features that could assist in screening and evaluating different chronic lung diseases. The EIT-derived indicators will be finally analyzed together with demographics, clinical assessments and patient history to derive fine grained insights and elucidate the effect of demographics and biometrics on EIT lung data. The parameters include, but not limited to, age, chest size, gender, weight, height, BMI, smoking habits and ethnicity. The analysis will improve the stability of the EIT indicators, and ultimately increase their predictive power towards diseased lung regions.
With the availability of the EIT device on lung function assessment, which was validated with spirometry findings, patients who are unable to perform spirometry but need a proper lung function assessment can benefit by having the EIT test. These patients include but not limited to those who need major lung resection and interstitial lung diseases on anti-fibrotic. EIT can also be a more comfortable alternative to spirometry for patients who need lung function assessment.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with underlying lung disease | – | Device: Electrical impedance tomography |
| Healthy subjects | – | Device: Electrical impedance tomography |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Pulmonary disease subjects Patients of age 18 to 75 suspected or diagnosed with pulmonary diseases scheduled to undergo standard pulmonary function test will be recruited. These patients will undergo an interview (with a structured questionnaire), Pulmonary Functional Test (PFT) and EIT examination. Healthy control subjects Healthy adults of age 18 to 75 who do not have any known pulmonary diseases will be examined. These healthy individuals will undergo spirometry and EIT examination, as well as an interview with a structured questionnaire to ensure they do not have any clinical features or symptoms.
Key inclusion criteria (2 listed)
- Pulmonary disease subjects Patients of age 18 to 75 suspected or diagnosed with pulmonary diseases scheduled to undergo standard pulmonary function test will be recruited. These patients will undergo an interview (with a structured questionnaire), Pulmonary Functional Test (PFT) and EIT examination.
- Healthy control subjects Healthy adults of age 18 to 75 who do not have any known pulmonary diseases will be examined. These healthy individuals will undergo spirometry and EIT examination, as well as an interview with a structured questionnaire to ensure they do not have any clinical features or symptoms.
Key exclusion criteria (5 listed)
- Subjects with implanted electronic devices, in case EIT might interfere with the devices
- Subjects with spinal diseases
- Subjects with unstable cardiac or respiratory conditions
- Pregnant women
- Patients who are unable to perform spirometry
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 |
|---|---|---|
| Electrical impedance tomographyElectrical impedance tomography (EIT) is a potential alternative non-invasive diagnostic screening measure to spirometry. | Device | Healthy subjects, Patients with underlying lung disease |
Primary outcome
Functional test comparison between spirometry and EIT lung device:
Time frame: 31/12/2022
This study will elucidate the feasibility of EIT in testing lung function in patients and compare its outcomes with the spirometry tests. We expect that the global EIT-derived functional parameters corroborate with spirometry results.
Regional lung function assessment in patients
Time frame: 31/12/2022
Regional EIT-derived structural and functional biomarkers of patients and healthy controls will be analyzed. This will potentially establish EIT-derived biomarkers for different chronic lung diseases.
Effect of demographics, clinical assessments and patient history on EIT measurements
Time frame: 31/12/2022
EIT derived indicators will be finally analyzed together with demographics, clinical assessments (including CT scans if available) and patient history to derive fine grained insights for potential early detection and treatment monitoring of different chronic lung diseases.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Individual participant dataSharing planned: Undecided
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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.
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 Lung Diseases, run by Queen Mary Hospital, Hong Kong at 1 site in Hong Kong.
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 18 Nov 2023. 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 Hong Kong. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional test comparison between spirometry and EIT lung device: (time frame: 31/12/2022). 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 18 Nov 2023.