UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048225 |
|---|---|
| Receipt number | R000054958 |
| Scientific Title | Diagnostic utility of diaphragm ultrasound and physical examinations in patients with COPD |
| Date of disclosure of the study information | 2022/07/01 |
| Last modified on | 2022/09/17 23:16:47 |
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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
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
as@ks.kyorin-u.ac.jp
Sponsor or person
Institute
Kyorin University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054958
