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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011017
Receipt No. 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

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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
Email 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
Email timz555jp@yahoo.co.jp

Sponsor
Institute Kumamoto Kinoh Hospital
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012899

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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