Healthy VolunteersNCT05565027
Efficacy and Safety of Pulmonary Function Analysis With Dynamic Digital Radiography Total Respiratory Cycle Photography
A study testing Dynamic digital radiography and Pneumotachograph in people with Healthy Volunteers, run by Shenzhen People's Hospital.
Trial summary
The digital X-ray system produced by Shenzhen Angell Technology Co., Ltd was selected as the tested equipment, and the powerlab biological signal acquisition and analysis system equipped with a pneumotachograph by ADInstruments was selected as the reference equipment. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Dynamic digital radiography and Pneumotachograph
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 20 Oct 2022to 20 Oct 2023
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ① age ≥ 18 years; ② subjects willing to undergo chest radiography; ③ normal pulmonary ventilation function (forced vital capacity (FVC) ≥ 80% of the expected value; forced expiratory volume in first second (FEV1) ≥ 80% of the expected value; 1 second rate (FEV1/FVC) ≥ 70%); ④ can perform tidal breathing, deep inspiration and deep expiration; ⑤ no history of smoking; ⑥ no history of chronic respiratory disease; ⑦ no acute respiratory disease within 4 weeks; ⑧ subjects willing to provide written informed consent
Who cannot join
- ① Pregnant and lactating women; ② Inability to stand alone; ③ Severe vertigo and other adverse reactions to rotation in place.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Efficacy and Safety of Pulmonary Function Analysis With Dynamic Digital Radiography Total Respiratory Cycle Photography in Healthy Volunteers
The digital X-ray system produced by Shenzhen Angell Technology Co., Ltd was selected as the tested equipment, and the powerlab biological signal acquisition and analysis system equipped with a pneumotachograph by ADInstruments was selected as the reference equipment. During the study, the lung volume measurements obtained by the lung function analysis method based on the dynamic digital radiography full respiratory cycle photography of the tested equipment was compared with the lung volume measurements obtained by the reference device pneumotachograph. The consistency of the lung volume measurements was used as the main validity evaluation index to observe the distribution of the differences between the measured values of the test device and the reference device, and to verify the validity of the declared product according to the main validity evaluation index.
Read the detailed description
Pulmonary function test is a test to explore the functional status of human respiratory system with the knowledge of exercise respiratory physiology and modern examination technology. It is an important test content for clinical diagnosis, severity assessment, treatment and prognosis assessment of chest and lung diseases, which has been widely used in the fields of respiratory medicine, surgery and anesthesiology. Compared with chest X-rays and CT examinations, which reflect the static function of the chest and lungs, pulmonary function tests can better reflect the dynamic functional changes of the body.
However, pulmonary function test is not well performed to assess the functional status in patients with poor cooperation (e.g., poor lung function, inability to understand cooperation). Dynamic digital X-ray whole respiratory cycle photography uses advanced dynamic radiography and acquisition technology to obtain high-definition dynamic lung images during the whole respiratory cycle of the patient, and uses the industry's first rotating foot pedal to rotate the patient to obtain weighted 3D scan data and single-angle or multi-angle lung data. The patient's lung function is analyzed by algorithmically extracting the patient's full respiratory cycle airway nodes and branches and data statistics. For patients who cannot cooperate with the lung function, it can provid information on the dynamic function of the patient's chest and lungs for doctors to further improve clinical diagnosis and treatment.
At present, the digital X-ray system (DTP580B-3) and the patient position fixation frame MRW-P1 manufactured by Shenzhen Angell Technology Co., Ltd. have passed the inspection by the inspection agency certified by the State Drug Administration of China (NMPA). Clinical trials were conducted to further evaluate the clinical effectiveness and safety of the products.
The lung volume was measured using a pneumotachograph (with a physiological signal recorder) and a digital X-ray system (UC dynamic DR) in the same healthy subject, and the lung volume values measured by each of the reference device were analyzed for consistency to evaluate the validity of the lung volume measurement by the test device. And To evaluate the safety of the lung volume measurement function of the test device in clinical use based on the occurrence of device malfunctions, adverse events and serious adverse events in the trial.
- Conditions
- Healthy Volunteers
- Being tested
- Dynamic digital radiography, Pneumotachograph
- Keywords
- dynamic digital X-ray, pulmonary function analysis, healthy volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynamic digital radiographyDevice
The use of advanced dynamic X-ray photography and acquisition technology can obtain high-definition dynamic lung images of patients throughout the respiratory cycle for analysis.
PneumotachographDevice
The pneumotachograph monitors the flow rate, and the lung volume is calculated by integrating.
| Study group | Role | What they receive |
|---|---|---|
| Pneumotachograph | Active comparator | The subject stood on the turntable of the instrument and grasped the postural fixator with both hands up. The subjects pinched their nose and breathed through the disposable filter mouthpiece connected to the pneumotachograph, taking care not to leak air at the corners of the mouth. The subjects were instructed to perform tidal breathing, deep inhalation, deep exhalation, etc., and to monitor lung volume by pneumotachograph. Receives: Device: Pneumotachograph |
| Dynamic digital radiography | Experimental | The subject stood on the turntable of the instrument and grasped the postural fixator with both hands up. The subjects pinched their nose and breathed through the disposable filter mouthpiece connected to the pneumotachograph, taking care not to leak air at the corners of the mouth. The subjects were instructed to perform tidal breathing, deep inhalation, deep exhalation, etc., and to monitor lung volume by dynamic digital radiography analysis. Receives: Device: Dynamic digital radiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung volume changes
The volume of gas inhaled/exhaled during each respiratory session of the subject during the monitoring period.
Measured: 1 day (The start time is when the subject is positioned and begins to breathe on command, and the end time is when the subject safely exits the x-ray system.)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2022
- Study start20 Oct 2022 (estimated)
- Primary completion20 Jul 2023 (estimated)
- Study completion20 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The subject stood on the turntable of the instrument and grasped the postural fixator with both hands up. The subjects pinched their nose and breathed through the disposable filter mouthpiece connected to the pneumotachograph, taking care not to leak air at the corners of the mouth. The subjects were instructed to perform tidal breathing, deep inhalation, deep exhalation, etc., and to perform dynamic DR photography and pneumotachograph monitoring simultaneously. At the end of the examination, assist the subjects to leave the examination equipment and re-measure their vital signs.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rongchang Chen, PhD, Study chair, Shenzhen People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05565027
- Sponsor's protocol ID
- 202101-02
- Status last verified
- Sep 2022
- First submitted
- 30 Sep 2022
- Last updated
- 4 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Pulmonary Function Analysis With Dynamic Digital Radiography Total Respiratory Cycle Photography in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT05565027
- Acronym / sponsor ID
- 202101-02
- Conditions
- Healthy Volunteers
- Keywords
- dynamic digital X-ray, pulmonary function analysis, healthy volunteers
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Shenzhen People's HospitalUniversity, hospital or other
- Study start
- 20 Oct 2022 (estimated)
- Primary completion
- 20 Jul 2023 (estimated)
- Study completion
- 20 Oct 2023 (estimated)
- First posted
- 4 Oct 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.
The digital X-ray system produced by Shenzhen Angell Technology Co., Ltd was selected as the tested equipment, and the powerlab biological signal acquisition and analysis system equipped with a pneumotachograph by ADInstruments was selected as the reference equipment. During the study, the lung volume measurements obtained by the lung function analysis method based on the dynamic digital radiography full respiratory cycle photography of the tested equipment was compared with the lung volume measurements obtained by the reference device pneumotachograph. The consistency of the lung volume measurements was used as the main validity evaluation index to observe the distribution of the differences between the measured values of the test device and the reference device, and to verify the validity of the declared product according to the main validity evaluation index.
Detailed description
Pulmonary function test is a test to explore the functional status of human respiratory system with the knowledge of exercise respiratory physiology and modern examination technology. It is an important test content for clinical diagnosis, severity assessment, treatment and prognosis assessment of chest and lung diseases, which has been widely used in the fields of respiratory medicine, surgery and anesthesiology. Compared with chest X-rays and CT examinations, which reflect the static function of the chest and lungs, pulmonary function tests can better reflect the dynamic functional changes of the body.
However, pulmonary function test is not well performed to assess the functional status in patients with poor cooperation (e.g., poor lung function, inability to understand cooperation). Dynamic digital X-ray whole respiratory cycle photography uses advanced dynamic radiography and acquisition technology to obtain high-definition dynamic lung images during the whole respiratory cycle of the patient, and uses the industry's first rotating foot pedal to rotate the patient to obtain weighted 3D scan data and single-angle or multi-angle lung data. The patient's lung function is analyzed by algorithmically extracting the patient's full respiratory cycle airway nodes and branches and data statistics. For patients who cannot cooperate with the lung function, it can provid information on the dynamic function of the patient's chest and lungs for doctors to further improve clinical diagnosis and treatment.
At present, the digital X-ray system (DTP580B-3) and the patient position fixation frame MRW-P1 manufactured by Shenzhen Angell Technology Co., Ltd. have passed the inspection by the inspection agency certified by the State Drug Administration of China (NMPA). Clinical trials were conducted to further evaluate the clinical effectiveness and safety of the products.
The lung volume was measured using a pneumotachograph (with a physiological signal recorder) and a digital X-ray system (UC dynamic DR) in the same healthy subject, and the lung volume values measured by each of the reference device were analyzed for consistency to evaluate the validity of the lung volume measurement by the test device. And To evaluate the safety of the lung volume measurement function of the test device in clinical use based on the occurrence of device malfunctions, adverse events and serious adverse events in the trial.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The subject stood on the turntable of the instrument and grasped the postural fixator with both hands up. The subjects pinched their nose and breathed through the disposable filter mouthpiece connected to the pneumotachograph, taking care not to leak air at the corners of the mouth. The subjects were instructed to perform tidal breathing, deep inhalation, deep exhalation, etc., and to perform dynamic DR photography and pneumotachograph monitoring simultaneously. At the end of the examination, assist the subjects to leave the examination equipment and re-measure their vital signs.
| Arm | Type | Receives |
|---|---|---|
| Pneumotachograph | Active comparator | Device: PneumotachographThe subject stood on the turntable of the instrument and grasped the postural fixator with both hands up. The subjects pinched their nose and breathed through the disposable filter mouthpiece connected to the pneumotachograph, taking care not to leak air at the corners of the mouth. The subjects were instructed to perform tidal breathing, deep inhalation, deep exhalation, etc., and to monitor lung volume by pneumotachograph. |
| Dynamic digital radiography | Experimental | Device: Dynamic digital radiographyThe subject stood on the turntable of the instrument and grasped the postural fixator with both hands up. The subjects pinched their nose and breathed through the disposable filter mouthpiece connected to the pneumotachograph, taking care not to leak air at the corners of the mouth. The subjects were instructed to perform tidal breathing, deep inhalation, deep exhalation, etc., and to monitor lung volume by dynamic digital radiography analysis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ① age ≥ 18 years; ② subjects willing to undergo chest radiography; ③ normal pulmonary ventilation function (forced vital capacity (FVC) ≥ 80% of the expected value; forced expiratory volume in first second (FEV1) ≥ 80% of the expected value; 1 second rate (FEV1/FVC) ≥ 70%); ④ can perform tidal breathing, deep inspiration and deep expiration; ⑤ no history of smoking; ⑥ no history of chronic respiratory disease; ⑦ no acute respiratory disease within 4 weeks; ⑧ subjects willing to provide written informed consent
Key exclusion criteria (1 listed)
- ① Pregnant and lactating women; ② Inability to stand alone; ③ Severe vertigo and other adverse reactions to rotation in place.
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 |
|---|---|---|
| Dynamic digital radiographyThe use of advanced dynamic X-ray photography and acquisition technology can obtain high-definition dynamic lung images of patients throughout the respiratory cycle for analysis. | Device | Dynamic digital radiography |
| PneumotachographThe pneumotachograph monitors the flow rate, and the lung volume is calculated by integrating. | Device | Pneumotachograph |
Primary outcome
Lung volume changes
Time frame: 1 day (The start time is when the subject is positioned and begins to breathe on command, and the end time is when the subject safely exits the x-ray system.)
The volume of gas inhaled/exhaled during each respiratory session of the subject during the monitoring period.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2022.
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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.
Rongchang Chen, PhD study chair
Shenzhen People's Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Dynamic digital radiography and Pneumotachograph in people with Healthy Volunteers, run by Shenzhen People's Hospital.
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 1 inclusion and 1 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 4 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
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 Jianyi Niu, MD (+8617825846046, niujianyi001@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lung volume changes (time frame: 1 day (The start time is when the subject is positioned and begins to breathe on command, and the end time is when the subject safely exits the x-ray system.)). 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 4 Oct 2022.