Electric ImpedanceNCT06359145
Prediction of COPD Severity Using Electrical Impedance Tomography
An observational study of Electric Impedance and Respiratory Function Tests, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
The purpose of this study is to predict the CT visual score of emphysema with EIT-based parameters, in order to provide a non-invasive and convenient method for the evaluation of lung structure and physiological and pathological progression of COPD. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Electric Impedance, Respiratory Function Tests, Pulmonary Disease, Chronic Obstructive
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2023to 1 Aug 2024
- 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Clinical physicians suspect a patient may have COPD based on symptoms and physical examination, but a definitive diagnosis has not been confirmed through PFTs.
Who may be able to join
- Clinical physicians suspect a patient may have COPD based on symptoms and physical examination, but a definitive diagnosis has not been confirmed through PFTs.
- Age > 20 years, and be able to communicate with doctors.
- Willing to sign informed consent for the course of the study.
Who cannot join
- Patient refusal of EIT examination.
- The CT scan information is incomplete, and the interval between the pulmonary function test and the CT scan is more than 180 days.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
PLA
Beijing, Beijing Municipality, 100853
Zhimei Duan, 13716376758, 549117002@qq.com
About this study
Official title: Prediction of COPD Chest CT Severity Using Electrical Impedance Tomography by Machine Learning Methods
The purpose of this study is to predict the CT visual score of emphysema with EIT-based parameters, in order to provide a non-invasive and convenient method for the evaluation of lung structure and physiological and pathological progression of COPD.
Read the detailed description
Methods: By collecting pulmonary function data, CT visual scores, and EIT data, and employing deep machine learning algorithms to compare the predictive capabilities of EIT and PFT for CT visual scores of pulmonary emphysema, this study aims to validate the ability of EIT to assess the progression of COPD.
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What is being measured
The primary outcome is the main question the study is designed to answer.
The predictive power of EIT and PFT for CT visual scoring of emphysema
the prediction accuracy between deep machine learning models based on PFT data and EIT data
Measured: 1 mounths
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2024
- Study start1 Apr 2023
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Electric ImpedanceStudies 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
- Other
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, wang kaifei, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06359145
- Sponsor's protocol ID
- EIT and COPD
- Status last verified
- Apr 2024
- First submitted
- 30 Mar 2024
- Last updated
- 11 Apr 2024
- Results posted
- No
- Data monitoring committee
- 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 11 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of COPD Chest CT Severity Using Electrical Impedance Tomography by Machine Learning Methods
- ClinicalTrials.gov ID
- NCT06359145
- Acronym / sponsor ID
- EIT and COPD
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Aug 2024 (estimated)
- First posted
- 11 Apr 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.
The purpose of this study is to predict the CT visual score of emphysema with EIT-based parameters, in order to provide a non-invasive and convenient method for the evaluation of lung structure and physiological and pathological progression of COPD.
Detailed description
Methods: By collecting pulmonary function data, CT visual scores, and EIT data, and employing deep machine learning algorithms to compare the predictive capabilities of EIT and PFT for CT visual scores of pulmonary emphysema, this study aims to validate the ability of EIT to assess the progression of COPD.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Clinical physicians suspect a patient may have COPD based on symptoms and physical examination, but a definitive diagnosis has not been confirmed through PFTs.
Key inclusion criteria (3 listed)
- Clinical physicians suspect a patient may have COPD based on symptoms and physical examination, but a definitive diagnosis has not been confirmed through PFTs.
- Age > 20 years, and be able to communicate with doctors.
- Willing to sign informed consent for the course of the study.
Key exclusion criteria (2 listed)
- Patient refusal of EIT examination.
- The CT scan information is incomplete, and the interval between the pulmonary function test and the CT scan is more than 180 days.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The predictive power of EIT and PFT for CT visual scoring of emphysema
Time frame: 1 mounths
the prediction accuracy between deep machine learning models based on PFT data and EIT data
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 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.
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 Electric Impedance and Respiratory Function Tests, run by Chinese PLA General 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 3 inclusion and 2 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 11 Apr 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 Zhimei Duan, doctor (13716376758, 549117002@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The predictive power of EIT and PFT for CT visual scoring of emphysema (time frame: 1 mounths). 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 11 Apr 2024; AzTrials last refreshed its copy on 1 Nov 2026.