jRCTs062210022招募中不适用
Development and evaluation of minimally invasive and dynamic respiratory function testing technology
未提供0 个研究点目标入组 150 人开始时间: 2022年7月8日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 主要终点
- AUC by ROC analysis of COPD stages
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Diagnostic Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 20age old over 至 No limit（—）
- 性别
- All
入选标准
- •COPD 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-
- •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.
- •Patients who was diagnosis COPD by pulmonorogist.
排除标准
- •1.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.
结局指标
主要结局
AUC by ROC analysis of COPD stages
AUC by ROC analysis of each stage of COPD and non-COPD
Correlation between dynamic image parameters and respiratory function test results
Correlation between dynamic image parameters calculated from dynamic X-ray images in healthy cases and respiratory function test results obtained by spirometry
次要结局
未报告次要终点
研究者
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