Efficacy and Safety of Pulmonary Function Analysis With Dynamic Digital Radiography Total Respiratory Cycle Photography
NCT05565027 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2022-10-04
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
Interventions
- DEVICE
-
Dynamic digital radiography
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.
- DEVICE
-
Pneumotachograph
The pneumotachograph monitors the flow rate, and the lung volume is calculated by integrating.
Sponsors & Collaborators
-
Shenzhen People's Hospital
lead OTHER
Principal Investigators
-
Rongchang Chen, PhD · Shenzhen People's Hospital
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- OTHER
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2022-10-20
- Primary Completion
- 2023-07-20
- Completion
- 2023-10-20
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