UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018236 |
|---|---|
| Receipt number | R000021111 |
| Scientific Title | An influence of tracheal cuff pressure under hypothermic cardioipulmonary bypass; Comparative study between Taper type tube and High pressure low volume cuff tube |
| Date of disclosure of the study information | 2015/07/07 |
| Last modified on | 2015/08/05 10:35:50 |
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Basic information
Public title
An influence of tracheal cuff pressure under hypothermic cardioipulmonary bypass; Comparative study between Taper type tube and High pressure low volume cuff tube
Acronym
An influence of tracheal cuff pressure under hypothermic cardioipulmonary bypass
Scientific Title
An influence of tracheal cuff pressure under hypothermic cardioipulmonary bypass; Comparative study between Taper type tube and High pressure low volume cuff tube
Scientific Title:Acronym
An influence of tracheal cuff pressure under hypothermic cardioipulmonary bypass
Region
| Japan |
Condition
Condition
Cardiac disease which needs cardiac surgery under hypothrmic cardiopulmonary bypass
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate cuff pressure changes of tracheal tube by using different tracheal tubes under hypothemic cardiopulmonary bypass
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
cuff pressure changes of tracheal tube
Key secondary outcomes
postoperative sore throat and hoarseness
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Taper tracheal tube
Interventions/Control_2
HVLP tracheal tube
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
cardiac surgery underhypothermic cardiopulmonary bypass
Key exclusion criteria
airway disease
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Minami Toshiaki |
Organization
Osaka Medical College
Division name
Anesthesiology
Zip code
Address
2-7 Daigaku-machi Takatsuki Osaka
TEL
072-683-1221
ane022@poh.osaka-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sawai Toshiyuki |
Organization
Osaka Medical College
Division name
Anesthesiology
Zip code
Address
2-7 Daigaku-machi Takatsuki Osaka
TEL
072-683-1221
Homepage URL
ane026@poh.osaka-med.ac.jp
Sponsor or person
Institute
Department of Anesthesiology Osaka Medical College
Institute
Department
Personal name
Funding Source
Organization
Osaka Medical College
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 | 07 | Month | 07 | 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
| 2015 | Year | 07 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 07 | Month | 06 | Day |
Last follow-up date
| 2018 | Year | 07 | Month | 06 | Day |
Date of closure to data entry
| 2018 | Year | 07 | Month | 06 | Day |
Date trial data considered complete
| 2018 | Year | 07 | Month | 06 | Day |
Date analysis concluded
| 2018 | Year | 07 | Month | 06 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 07 | Month | 07 | Day |
Last modified on
| 2015 | Year | 08 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021111
