UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010007 |
|---|---|
| Receipt number | R000011720 |
| Scientific Title | Evaluation of Lung Ventilation and Perfusion by Capnometer |
| Date of disclosure of the study information | 2013/02/10 |
| Last modified on | 2021/02/24 16:15:03 |
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Basic information
Public title
Evaluation of Lung Ventilation and Perfusion by Capnometer
Acronym
Intrabronchial Capnography
Scientific Title
Evaluation of Lung Ventilation and Perfusion by Capnometer
Scientific Title:Acronym
Intrabronchial Capnography
Region
| Japan |
Condition
Condition
bronchial stenosis
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To estimate the regional gas exchange by measuring carbon dioxide (CO2) concentration during bronchoscopy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
End - tidal carbon dioxide (EtCO2) concentration before and after interventional bronchoscopy
Key secondary outcomes
Lung ventilation and perfusion status before and after interventional bronchoscopy.
Lung ventilation and perfusion status at lobar bronchi during bronchoscopy.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
For patients with bronchial stenosis or COPD.
CO2 concentration was measured using a catheter at trachea, main bronchi and lobar bronchi during bronchoscopy.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Bronchoscopy is performed in patients with bronchial stenosis or COPD.
Key exclusion criteria
Patients with sever pulmonary dysfunction
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masamichi Mineshita |
Organization
St. Marianna University School of Medicine
Division name
Division of Respiratory Diseases, Department of Internal Medicine
Zip code
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki, Japan 216-8511
TEL
044-977-8111
m-mine@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroki Nishine |
Organization
St. Marianna University School of Medicine
Division name
Division of Respiratory Diseases, Department of Internal Medicine
Zip code
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki, Japan 216-8511
TEL
044-977-8111
Homepage URL
h2nishine@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
St. Marianna University School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2013 | Year | 02 | Month | 10 | 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
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
| 2011 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2011 | Year | 07 | Month | 26 | Day |
Anticipated trial start date
| 2011 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2019 | Year | 03 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 02 | Month | 10 | Day |
Last modified on
| 2021 | Year | 02 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011720
