UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024867 |
|---|---|
| Receipt number | R000027610 |
| Scientific Title | Effectiveness of exhaled carbon dioxide monitoring by bite-block shape adapter during Endoscopic Retrograde Cholangiopancreatography |
| Date of disclosure of the study information | 2016/11/18 |
| Last modified on | 2019/12/25 20:21:54 |
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Basic information
Public title
Effectiveness of exhaled carbon dioxide monitoring by bite-block shape adapter during Endoscopic Retrograde Cholangiopancreatography
Acronym
Effectiveness of exhaled carbon dioxide monitoring by bite-block shape adapter during ERCP
Scientific Title
Effectiveness of exhaled carbon dioxide monitoring by bite-block shape adapter during Endoscopic Retrograde Cholangiopancreatography
Scientific Title:Acronym
Effectiveness of exhaled carbon dioxide monitoring by bite-block shape adapter during ERCP
Region
| Japan |
Condition
Condition
patients who undergo endoscopic retrograde cholangiopancreatography at Keio university hospital
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to detect respiratory depression earlier than before
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Hypoxemia
Key secondary outcomes
Detection of apnea,respiratory depression detected by end-tidal CO2 abnormalities,Death,vital sign parameters,Patient satisfaction,Patient cooperation rated by the endoscopist,Time from end of endoscopy,procedural parameters, Early procedure termination,other complication
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients who undergo ERCP at Keio university hospital
Key exclusion criteria
patients under the age of 20,those who have dementia,and people who sufficient informed consent cannot be obtained from
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Takehiro |
| Middle name | |
| Last name | Masaoka |
Organization
Keio university school of medcine
Division name
gastroenterology and hepatology
Zip code
1608582
Address
35 Shinanomachi,Shinjyuku-ku,Tokyo,Japan
TEL
0333531211
masaoka@keio.jp
Public contact
Name of contact person
| 1st name | Eisuke |
| Middle name | |
| Last name | Iwasaki |
Organization
Keio university school of medcine
Division name
gastroenterology and hepatology
Zip code
1608582
Address
35 Shinanomachi,Shinjyuku-ku,Tokyo,Japan
TEL
0333531211
Homepage URL
iwaiwa2007@gmail.com
Sponsor or person
Institute
Keio university school of medcine
Institute
Department
Personal name
Funding Source
Organization
NIHON KOHDEN CORPORATION
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University
Address
35 Shinanomachi,Shinjyuku-ku,Tokyo,Japan
Tel
0333531211
yoichi_tak2005@yahoo.co.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
| 2016 | Year | 11 | Month | 18 | 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
| 2016 | Year | 08 | Month | 08 | Day |
Date of IRB
| 2016 | Year | 08 | Month | 08 | Day |
Anticipated trial start date
| 2016 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2016 | Year | 11 | Month | 16 | Day |
Last modified on
| 2019 | Year | 12 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027610
