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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000031474
Receipt No. R000035925
Scientific Title the relation between support method of spiral tube during general anesthesia and postoperative sore throat : single center randomized controlled study
Date of disclosure of the study information 2018/02/27
Last modified on 2019/06/23

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Basic information
Public title the relation between support method of spiral tube during general anesthesia and postoperative sore throat : single center randomized controlled study
Acronym the relation between support method of spiral tube during general anesthesia and postoperative sore throat
Scientific Title the relation between support method of spiral tube during general anesthesia and postoperative sore throat : single center randomized controlled study
Scientific Title:Acronym the relation between support method of spiral tube during general anesthesia and 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 objective is to evaluate whether the support method of tracheal tube affect the incidence of postoperative sore throat.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes postoperative sore throat
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 tube in curved state
Interventions/Control_2 To support the tube in natural state
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
18 years-old <=
Age-upper limit
85 years-old >
Gender Male and Female
Key inclusion criteria Patients undergoing general anesthesia
Key exclusion criteria Except for the head and neck surgery,smoker, cases that could not be intubated in one trial and patients suffering from upper respiratory inflammation within 2 weeks
Target sample size 160

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuichi Yaguchi
Organization Hitachi general hospital
Division name Department of Anesthesiology
Zip code
Address 2-1-1, jonan-cho, hitachi, Ibaraki prefecture
TEL 0294-23-1111
Email yuichi.yaguchi.tj@hitachi.com

Public contact
Name of contact person
1st name
Middle name
Last name Yuto Hamaguchi
Organization Hitachi general hospital
Division name Department of Anesthesiology
Zip code
Address 2-1-1, jonan-cho, hitachi, Ibaraki prefecture
TEL 0294-23-1111
Homepage URL
Email yhamaguchi0305@gmail.com

Sponsor
Institute Hitachi general hospital
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
2018 Year 02 Month 27 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
2017 Year 09 Month 01 Day
Date of IRB
2017 Year 09 Month 01 Day
Anticipated trial start date
2018 Year 01 Month 20 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 02 Month 26 Day
Last modified on
2019 Year 06 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035925

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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