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Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000006037
Receipt No. 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

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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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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
Email 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
Email fumi1224@med.shimane-u.ac.jp

Sponsor
Institute Shimane University Faculty of Medicine
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007148


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