ew pulmonary function assessment using chest X-ray dynamic digital radiography

Not Applicable

• Conditions: Chronic obstructive pulmonary disease (COPD), In terstitial lung disease (ILD)

• Registration Number: JPRN-jRCTs042220018
• Lead Sponsor: Ohkura Noriyuki

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-05-19
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

Patients who meet all of the following conditions.
1) Patients who visit the Department of Respiratory Surgery or the Department of Respiratory Medicine at our hospital and are classified by respiratory function tests as 1) COPD patients, 2) ILD patients, 3) patients with mixed ventilation disorder, or 4) patients with normal respiratory function.
2) Age 20 years or older at the time of obtaining written consent.
3) Able to hold a standing position during radiography.
4) Able to take deep breaths and hold breaths according to the respiratory protocol during radiography.
5) Written consent has been obtained from the patient himself/herself after sufficient informed consent for participation in the clinical study.

Exclusion Criteria

Patients who meet one or more of the following conditions.
1) The patient is pregnant or may become pregnant.
2) Patients who are judged by the principal investigator or sub-investigator to be unsuitable as research subjects.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary endpoint 1: Diagnosis of obstructive ventilatory disorder (FEV1/FVC <0.7) by chest X-ray dynamic digital radiography.<br>Primary endpoint 2: Diagnosis of restrictive ventilatory disorder (predictive vital capacity <80%) by chest X-ray dynamic digital radiography.

Secondary Outcome Measures

Name	Time	Method
1) Detection of mixed ventilatory impairment (1 sec/lung volume <0.7 and predicted lung volume <80%)<br>2) Dynamic parameters (maximum lung field area, tracheal stenosis rate, lung field area change rate) using chest X-ray dynamic analysis of frontal + lateral chest X-ray images<br>3) Respiratory function (VC, FVC)<br>4) Dyspnea grade (mMRC grade)<br>5) Health-related quality of life (CAT score)<br>6) Lung fields of ventilation analysis images generated from X-ray dynamic images<br>6) Analysis signal values for the entire lung field and upper, middle and lower lung fields (pulmonary ventilation mapping image)<br>(7) Analyzed signal values for the entire lung fields and the upper, middle, and lower lung fields in the blood flow analysis image generated from the X-ray dynamic image (pulmonary blood flow mapping image)<br><br>Translated with www.DeepL.com/Translator (free version)