NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs062210022

Registered date:08/07/2021

Development of dynamic X-ray inspection technology

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedChronic obstructive pulmonary disease
Date of first enrollment01/07/2021
Target sample size1000
Countries of recruitment
Study typeInterventional
Intervention(s)Conducting X-ray dynamic image inspection by a dynamic flat-panel detector system

Outcome(s)

Primary Outcome1.Correlation between dynamic image parameters calculated from dynamic X-ray images in healthy cases and respiratory function test results obtained by spirometry. 2.AUC by ROC analysis of each stage of COPD and non-COPD.
Secondary OutcomeCorrelation of dynamic x-ray parameters with mMRC shortness of breath scale and CAT

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximumNot applicable
GenderBoth
Include criteriaCOPD patients who are admitted or attended the Shimane University Hospital and healthy volunteers(patients without respiratory dysfunction who are admitted or attended the Shimane University Hospital, medical examination participants, Hospital staff medical examination perticipants and students) For healthy volunteers, those who meet the following 1-3. 1.Persons aged 20 years and over at the time of consent. 2.Persons who are possible labored breathing, resting breathing and breath holding in the standing or lying position. 3.Persons who have received sufficient explanation before participating in this study, and have obtained written consent by their own free will with sufficient understanding. For COPD patients, those who meet the following 1-4 1.Patients aged 20 years and over at the time of consent. 2.Patients who are possible labored breathing, resting breathing and breath holding in the standing or lying position. 3.Patients who have received sufficient explanation before participating in this study, and have obtained written consent by their own free will with sufficient understanding. 4. Patients who was diagnosis COPD by pulmonorogist.
Exclude criteria1.Persons who do not understand the breathing instructions at the time of examination(ex;dementia) 2.Persons with a history of thoracic surgery beyond lobectomy and radiation therapy to the chest. 3.People who are currently admitting or attending the department of respiratory medicine because of respiratory dysfunction other than COPD. 4.Women who are currently pregnant, may be pregnant or breastfeeding. 5.Persons with an implantable pacemaker or implantable defibrillator. 6.Other persons who are judged to be inappropriate by the investigator and the investigator.

Related Information

Contact

Public contact
Name Megumi Hamaguchi
Address 89-1, Enya-cho, Izumo-shi, Shimane Shimane Japan 693-8501
Telephone +81-853-20-2580
E-mail hs1219@med.shimane-u.ac.jp
Affiliation Shimane University Hospital
Scientific contact
Name Takeshi Isobe
Address 89-1, Enya-cho, Izumo-shi, Shimane Shimane Japan 693-8501
Telephone +81-853-20-2580
E-mail isobeti@med.shimane-u.ac.jp
Affiliation Shimane University Hospital