Efficacy and Safety of Pulmonary Function Analysis With Dynamic Digital Radiography Total Respiratory Cycle Photography

NCT05565027 | Unknown

• 1 other identifier: 202101-02
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Healthy Volunteers

Keywords

dynamic digital X-ray; pulmonary function analysis; healthy volunteers

Outcome Measures

Primary Outcomes (1)

• Lung volume changes

  The volume of gas inhaled/exhaled during each respiratory session of the subject during the monitoring period.

  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.)

Study Arms (2)

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.

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.

Device: Dynamic digital radiography

Interventions

Dynamic digital radiography DEVICE

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.

Dynamic digital radiography

Pneumotachograph DEVICE

The pneumotachograph monitors the flow rate, and the lung volume is calculated by integrating.

Pneumotachograph

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• ① Pregnant and lactating women; ② Inability to stand alone; ③ Severe vertigo and other adverse reactions to rotation in place.

Sponsors & Collaborators

• Shenzhen People's Hospital: lead

Study Officials

• Rongchang Chen, PhD

  Shenzhen People's Hospital

  STUDY CHAIR

Central Study Contacts

Jianyi Niu, MD

CONTACT

+8617825846046; niujianyi001@163.com

Lili Guan, PhD

CONTACT

+8617825846046; dr_nickguan@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Lung volume measurements using the test and reference devices were clearly different and could not be blinded to subjects and investigators, so an open trial design was used.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 30, 2022
• First Posted: October 4, 2022
• Study Start: October 20, 2022
• Primary Completion: July 20, 2023
• Study Completion: October 20, 2023
• Last Updated: October 4, 2022

Record last verified: 2022-09