UMIN-CTR Clinical Trial

Basic information
Public title	Diagnostic utility of diaphragm ultrasound and physical examinations in patients with COPD
Acronym	Diagnostic utility of diaphragm ultrasound and physical examinations in patients with COPD
Scientific Title	Diagnostic utility of diaphragm ultrasound and physical examinations in patients with COPD
Scientific Title:Acronym	Diagnostic utility of diaphragm ultrasound and physical examinations in patients with COPD
Region	Japan

Condition
Condition	Chronic Obstructive Lung Disease
Classification by specialty	Medicine in general Pneumology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The main objective of this study was to explore the utility of physical examinations and diaphragm ultrasound for predicting the severity of the airflow limitation.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The sensitivity, specificity, liklihood ratio, and correctivity of the total number of abnormal physical signs or diaphragm ultrasound to diagnose Stage 3, 4 COPD
Key secondary outcomes

Base
Study type	Others,meta-analysis etc

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	The patients previously diagnosed by Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria were recruited using the convenience sampling method. The patients admitted to the hospital to introduce home oxygen therapy (HOT) for chronic worsening exertional hypo-oxygenation were also included.
Key exclusion criteria	The exclusion criteria were the patients who had acute diseases between two months before and after the study, active cancer, or neuromuscular diseases.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Sunao Middle name Last name Mikura
Organization	Kyorin University Hospital
Division name	Respiratory medicine
Zip code	1818611
Address	6-20-2,Shinkawa, Mitaka, Tokyo, Japan
TEL	0422475511
Email	as@ks.kyorin-u.ac.jp

Public contact
Name of contact person	1st name Sunao Middle name Last name Mikura
Organization	Kyorin University Hospital
Division name	Respiratory medicine
Zip code	1818611
Address	6-20-2,Shinkawa, Mitaka, Tokyo, Japan
TEL	0422475511
Homepage URL
Email	as@ks.kyorin-u.ac.jp

Sponsor
Institute	Kyorin University Hospital
Institute
Department

Funding Source
Organization	Ministry of Education, Culture, Sports, Science, and Technology-Japan
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	The ethical comittee of Kyorin University
Address	6-20-2,Shinkawa, Mitaka, Tokyo, Japan
Tel	0422475511
Email	irb@ks.kyorin-u.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2022 Year 07 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	25
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 01 Month 17 Day
Date of IRB	2018 Year 01 Month 17 Day
Anticipated trial start date	2018 Year 01 Month 17 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2022 Year 03 Month 31 Day

Other
Other related information	cross-sectional study

Management information
Registered date	2022 Year 07 Month 01 Day
Last modified on	2022 Year 09 Month 17 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054958