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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000025135
Receipt No. R000028227
Scientific Title Effects of support method of tracheal tube in general anesthesia on postoperative sore throat
Date of disclosure of the study information 2016/12/05
Last modified on 2018/06/19

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Basic information
Public title Effects of support method of tracheal tube in general anesthesia on postoperative sore throat
Acronym Effects of support method of tracheal tube in general anesthesia on postoperative sore throat
Scientific Title Effects of support method of tracheal tube in general anesthesia on postoperative sore throat
Scientific Title:Acronym Effects of support method of tracheal tube in general anesthesia on postoperative sore throat
Region
Japan

Condition
Condition Patients undergoing general anesthesia
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The patients who underwent surgery under general anesthesia requiring tracheal intubation to the subject at the University of Tsukuba University Hospital, incidence of postoperative sore throat in support two methods of tracheal tube and a comparative study whether the difference in the degree occurs do. We support the method of tracheal tube was hypothesized that does not affect the onset of post-operative sore throat. So to speak, in which the present study for the safety check is carried out.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes If familiar with the support method of the tracheal tube is induced sore throat occur, there is a need to review the method of supporting the tracheal tube.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control No treatment
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as a block.
Blocking YES
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 To support the addition of curved to the tracheal tube
Interventions/Control_2 Support without the addition of curved 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
80 years-old >
Gender Male and Female
Key inclusion criteria Patients undergoing general anesthesia
Key exclusion criteria Except for the head and neck surgery,smoker,Detain a stomach tube and Cases that could not be intubated in one trial
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tsuyoshi Satumae
Organization University of Tsukuba medical clinical medicine
Division name anesthesia
Zip code
Address 2-1-1 Tenkubo Tsukuba, Ibaraki prefecture
TEL 029-853-3092
Email tsuu@md.tsukuba.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Musashi Yahagi
Organization Tsukuba University Hospital
Division name Department of Anesthesiology
Zip code
Address 2-1-1 Tenkubo Tsukuba, Ibaraki prefecture
TEL 029-853-3092
Homepage URL
Email musasum0710@yahoo.co.jp

Sponsor
Institute University of Tsukuba Anesthesiology Department
Institute
Department

Funding Source
Organization no
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
2016 Year 12 Month 05 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 No longer recruiting
Date of protocol fixation
2016 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 08 Month 01 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
2016 Year 12 Month 04 Day
Last modified on
2018 Year 06 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028227

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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