UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011017 |
|---|---|
| Receipt number | R000012899 |
| Scientific Title | Effect of removing complete dentures on nasopharyngeal patency during induction of general anesthesia |
| Date of disclosure of the study information | 2013/06/22 |
| Last modified on | 2014/12/29 16:00:35 |
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Basic information
Public title
Effect of removing complete dentures on nasopharyngeal patency during induction of general anesthesia
Acronym
Effect of removing complete dentures on nasopharyngeal patency during induction of general anesthesia
Scientific Title
Effect of removing complete dentures on nasopharyngeal patency during induction of general anesthesia
Scientific Title:Acronym
Effect of removing complete dentures on nasopharyngeal patency during induction of general anesthesia
Region
| Japan |
Condition
Condition
Patients wearing complete dentures that undergo elective surgery under general anesthesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To test the hypothesis that removing complete dentures limit nasopharyngeal patency during induction of general anesthesia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes in nasopharyngeal patency before and after removing complete dentures.
Waveform patterns of capnography sampled at nasal vestibule.
Key secondary outcomes
Changes in nasopharyngeal patency before and after removing complete dentures.
Nasopharyngeal obstruction is estimated using a 3-point scale defined by the expansion of lips and cheeks after mask-ventilation in subjects which mouth is airtight sealed.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Changes in the degree of nasopharyngeal obstruction are estimated between subjects wearing and removing complete dentures during induction of general anesthesia.
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
Elective surgical patients wearing complete dentures under general anesthesia
Key exclusion criteria
Emergency surgery, previous or predicted difficult airway cases, high risk of aspiration, severe nasal stuffiness
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Imaizumi |
Organization
Kumamoto Kinoh Hospital
Division name
division of anesthesia
Zip code
Address
6-8-1, Yamamuro, Kita-ku, Kumamoto
TEL
096-345-8111
timz555jp@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takashi Imaizumi |
Organization
Kumamoto Kinoh Hospital
Division name
division of anesthesia
Zip code
Address
6-8-1, Yamamuro, Kita-ku, Kumamoto
TEL
096-345-8111
Homepage URL
timz555jp@yahoo.co.jp
Sponsor or person
Institute
Kumamoto Kinoh Hospital
Institute
Department
Personal name
Funding Source
Organization
Kumamoto Kinoh Hospital
Organization
Division
Category of Funding Organization
Other
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
| 2013 | Year | 06 | Month | 22 | 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
| 2012 | Year | 07 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 09 | Month | 24 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 06 | Month | 22 | Day |
Last modified on
| 2014 | Year | 12 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012899
