Tomography, Optical CoherenceNCT05692362
Measure Airway Compliance by Endobronchial Optical Coherence Tomography
An observational study of Tomography, Optical Coherence and Bronchoscopy, run by The First Affiliated Hospital of Guangzhou Medical University at 1 site in China.
Trial summary
Optical Coherence Tomography （OCT）is a novel, non-invasive, high resolution special optical imaging techniques. In airway, Measure airway area and airway wall thickness is the most usage of Endobronchial Optical Coherence Tomography (EB-OCT）. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Tomography, Optical Coherence, Bronchoscopy, Respiratory Disease
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2023to 31 Dec 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy People and People with COPD or asthma 、 restrictive pulmonary diseases.
Who may be able to join
- Regardless of gender, age 18-70 years old;
- Patients with clinical diagnosis of pulmonary nodules, COPD, asthma or restrictive pulmonary diseases;
- Can tolerate bronchoscopy patients;
- Sign the informed consent form.
Who cannot join
- Suffering from any of the following respiratory diseases: bronchiectasis, etc;
- Have malignant tumors that are not completely remission or cured;
- The patient's systemic infection is not controlled;
- Recent use of immunosuppressants, recent use of anticoagulants (such as warfarin or aspirin within 2 weeks of drugs that affect blood clotting function);
- Serious other systemic diseases: myocardial infarction, unstable angina, cirrhosis, acute glomerulonephritis, etc.;
- Those who are positive for syphilis, HIV, HBV, and HCV antibodies;
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- Patients with coagulation dysfunction diseases, such as hemophilia, giant platelet syndrome, platelet weakness, etc.;
- Severe renal impairment, serum creatinine > 1.5 times the upper limit of normal value;
- Liver disease or liver function impairment: ALT, AST, total bilirubin > 2 times the upper limit of normal value;
- Those with a history of mental illness or suicide, a history of epilepsy or other central nervous system diseases;
- 12-lead ECG showing severe arrhythmias (such as ventricular tachycardia, frequent supraventricular tachycardia, atrial fibrillation, atrial flutter, etc.) or conduction abnormalities of the heart of grade II and above;
- Those who are allergic to catheters and related materials required for experiments;
- Subjects who have received any other clinical studies within 3 months prior to enrollment;
- Those who have poor compliance and difficulty in completing the study;
- Any condition that the clinician believes may increase the risk to the patient or interfere with the clinical study.
Trial locations and contacts
1 site in 1 country.
About this study
Optical Coherence Tomography （OCT）is a novel, non-invasive, high resolution special optical imaging techniques. In airway, Measure airway area and airway wall thickness is the most usage of Endobronchial Optical Coherence Tomography (EB-OCT）. Recently, the new protocol of EB-OCT is used to measure airway compliance, We will establish a new methodology of EB-OCT for measuring airway compliance, which will provide a new means to study respiratory diseases.
- Keywords
- EB-OCT, Airway Compliance, Airway Remodeling
- Medical subject headings
- Respiration Disorders, Airway Remodeling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy People | People with solitary pulmonary nodule， without any other pulmonary diseases. | |
| Chronic Airway Diease People | People with COPD or Asthma | |
| Pulmonary fibrosis people | People were diagnosised pulmonary fibrosis by chest Computer Tomography, and restrictive ventilatory impairment by pulmonary function test. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Airway Compliance of different airway generation
Airway compliance is the property of the airway lumen area to change as pressure changes. This is caused by airway structure, the small airway without cartilage compared with medium and large airways, so the compliance would be different.
But the methods of measuring airway compliance is difficult, In this research, we will use OCT to measure airway area (mm2), and record the airway pressure(cmH2O), The ratio of area change to pressure change is the compliance, we will measure and compare the compliance of different airway generation.
Measured: 2023/01/01-2024/12/31
Secondary outcomes (1)
Airway Compliance of different people
Airway compliance is the property of the airway lumen area to change as pressure changes. This is caused by airway structure, the airway of COPD, asthma or pulmonary fibrosis compared to healthy people are different, so the compliance would be different.
But the methods of measuring airway compliance is difficult, In this research, we will use OCT to measure airway area (mm2), and record the airway pressure(cmH2O), The ratio of area change to pressure change is the compliance, we will measure and compare the compliance of different people.
Measured: 2023/01/01-2024/12/31
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2023
- Study start1 Mar 2023 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tomography, Optical CoherenceStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Guangzhou Medical UniversityThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xu Hang, The First Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05692362
- Sponsor's protocol ID
- GYFYY20221108
- Status last verified
- Jan 2023
- First submitted
- 4 Jan 2023
- Last updated
- 20 Jan 2023
- 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 20 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measure Airway Compliance by Endobronchial Optical Coherence Tomography
- ClinicalTrials.gov ID
- NCT05692362
- Acronym / sponsor ID
- GYFYY20221108
- Keywords
- EB-OCT, Airway Compliance, Airway Remodeling
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Guangzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Mar 2023 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 20 Jan 2023 (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.
Optical Coherence Tomography （OCT）is a novel, non-invasive, high resolution special optical imaging techniques. In airway, Measure airway area and airway wall thickness is the most usage of Endobronchial Optical Coherence Tomography (EB-OCT）. Recently, the new protocol of EB-OCT is used to measure airway compliance, We will establish a new methodology of EB-OCT for measuring airway compliance, which will provide a new means to study respiratory diseases.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy People | – | –People with solitary pulmonary nodule， without any other pulmonary diseases. |
| Chronic Airway Diease People | – | –People with COPD or Asthma |
| Pulmonary fibrosis people | – | –People were diagnosised pulmonary fibrosis by chest Computer Tomography, and restrictive ventilatory impairment by pulmonary function test. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy People and People with COPD or asthma 、 restrictive pulmonary diseases.
Key inclusion criteria (4 listed)
- Regardless of gender, age 18-70 years old;
- Patients with clinical diagnosis of pulmonary nodules, COPD, asthma or restrictive pulmonary diseases;
- Can tolerate bronchoscopy patients;
- Sign the informed consent form.
Key exclusion criteria (15 listed)
- Suffering from any of the following respiratory diseases: bronchiectasis, etc;
- Have malignant tumors that are not completely remission or cured;
- The patient's systemic infection is not controlled;
- Recent use of immunosuppressants, recent use of anticoagulants (such as warfarin or aspirin within 2 weeks of drugs that affect blood clotting function);
- Serious other systemic diseases: myocardial infarction, unstable angina, cirrhosis, acute glomerulonephritis, etc.;
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
Airway Compliance of different airway generation
Time frame: 2023/01/01-2024/12/31
Airway compliance is the property of the airway lumen area to change as pressure changes. This is caused by airway structure, the small airway without cartilage compared with medium and large airways, so the compliance would be different. But the methods of measuring airway compliance is difficult, In this research, we will use OCT to measure airway area (mm2), and record the airway pressure(cmH2O), The ratio of area change to pressure change is the compliance, we will measure and compare the compliance of different airway generation.
1 secondary outcome
Airway Compliance of different people
Time frame: 2023/01/01-2024/12/31
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Tomography, Optical Coherence and Bronchoscopy, run by The First Affiliated Hospital of Guangzhou Medical University 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 4 inclusion and 15 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 20 Jan 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 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Airway Compliance of different airway generation (time frame: 2023/01/01-2024/12/31). 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 20 Jan 2023.