UMIN-CTR Clinical Trial

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	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled	30
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	2016 Year 08 Month 01 Day
Date of IRB	2016 Year 09 Month 01 Day
Anticipated trial start date	2016 Year 08 Month 01 Day
Last follow-up date	2021 Year 09 Month 01 Day
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	2021 Year 11 Month 24 Day

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