UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018728 |
|---|---|
| Receipt number | R000021664 |
| Scientific Title | Cuff pressure of tracheal tube during gynecologic surgery with laparoscopic compared with those with laparotomy; continuous monitoring |
| Date of disclosure of the study information | 2015/09/01 |
| Last modified on | 2015/08/19 15:22:29 |
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Basic information
Public title
Cuff pressure of tracheal tube during gynecologic surgery with laparoscopic compared with those with laparotomy; continuous monitoring
Acronym
Cuff pressure of tracheal tube
Scientific Title
Cuff pressure of tracheal tube during gynecologic surgery with laparoscopic compared with those with laparotomy; continuous monitoring
Scientific Title:Acronym
Cuff pressure of tracheal tube
Region
| Japan |
Condition
Condition
gynecologic surgery
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
examination for variation of cuff pressure
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
cuff pressure
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
| 20 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Female
Key inclusion criteria
ASA 1-2
Key exclusion criteria
Upper respiratory tract inflammation (within two weeks)
A chronic laryngopharynx disease and chronic lung disease
Tracheotomy career, anatomical abnormality of the respiratory tract
History and expectation of difficulty intubation
Difficulty communication
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kentaro Ouchi |
Organization
Kyushu University
Division name
Denral science
Zip code
Address
3-1-1, Maidashi, HIgashi-ku, Fukuoka city
TEL
092-641-1151
ken2006anes@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kentaro OUCHI |
Organization
Kyushu University
Division name
Denral science
Zip code
Address
3-1-1, Maidashi, HIgashi-ku, Fukuoka city
TEL
092-641-1151
Homepage URL
ken2006anes@yahoo.co.jp
Sponsor or person
Institute
Kyushu University
Institute
Department
Personal name
Funding Source
Organization
Kyushu University
Organization
Division
Category of Funding Organization
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
| 2015 | Year | 09 | 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
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
Open public recruiting
Date of protocol fixation
| 2015 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 08 | Month | 15 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Cuff pressure was measured during operation
Management information
Registered date
| 2015 | Year | 08 | Month | 19 | Day |
Last modified on
| 2015 | Year | 08 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021664
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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