UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006037 |
|---|---|
| Receipt number | R000007148 |
| Scientific Title | clinical trial of circulatory hemodynamics during bronchoscopy |
| Date of disclosure of the study information | 2011/07/27 |
| Last modified on | 2015/01/26 09:12:10 |
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Basic information
Public title
clinical trial of circulatory hemodynamics during bronchoscopy
Acronym
clinical trial of circulatory hemodynamics during bronchoscopy
Scientific Title
clinical trial of circulatory hemodynamics during bronchoscopy
Scientific Title:Acronym
clinical trial of circulatory hemodynamics during bronchoscopy
Region
| Japan |
Condition
Condition
subjects of bronchoscopy
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
Consider the following items in order to implement safer bronchoscopy.
1 cardiorespiratory dynamics
2 measuring biomarkers (salivary amylase) to examine the stress of bronchoscopy
3 conducting a survey patients after bronchoscopy to examine the degree of patient distress
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1 BNP levels in the blood
2 salivary amylase levels before and after bronchoscopy
3 cardiorespiratory dynamics monitoring during bronchoscopy
4 patient pain questionnaire after bronchoscopic
Key secondary outcomes
Base
Study type
Observational
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
1 subject of a bronchoscopy
2 patients over 18 years of age
3 cases written informed consent was obtained
Key exclusion criteria
patients who were deemed inappropriate to the subject of this study by attending physician
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | FumiKARINO |
Organization
Shimane University Faculty of Medicine
Division name
Oncology and Respiratory Medicine
Zip code
Address
89-1 Enya-cho Izumo Shimane 693-8501 JAPAN
TEL
0853-20-2580
fumi1224@med.shimane-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | FumiKARINO |
Organization
Shimane University Faculty of Medicine
Division name
Oncology and Respiratory Medicine
Zip code
Address
89-1 Enya-cho Izumo Shimane 693-8501 JAPAN
TEL
0853-20-2580
Homepage URL
fumi1224@med.shimane-u.ac.jp
Sponsor or person
Institute
Shimane University Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
Shimane University Faculty 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
| 2011 | Year | 07 | Month | 27 | 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
Enrolling by invitation
Date of protocol fixation
| 2010 | Year | 11 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 11 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Consider the following items in order to implement safer bronchoscopy.
1 cardiorespiratory dynamics
2 measuring biomarkers (salivary amylase) to examine the stress of bronchoscopy
3 conducting a survey patients after bronchoscopy to examine the degree of patient distress
Management information
Registered date
| 2011 | Year | 07 | Month | 25 | Day |
Last modified on
| 2015 | Year | 01 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007148
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
