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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000021863
Receipt No. R000025206
Scientific Title A randomised controlled trial comparing gastric tube insertion for the Laryngeal Mask Airway Flexible.
Date of disclosure of the study information 2016/04/11
Last modified on 2016/04/11

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Basic information
Public title A randomised controlled trial comparing gastric tube insertion for the Laryngeal Mask Airway Flexible.
Acronym A randomised controlled trial comparing gastric tube insertion for the Laryngeal Mask Airway Flexible.
Scientific Title A randomised controlled trial comparing gastric tube insertion for the Laryngeal Mask Airway Flexible.
Scientific Title:Acronym A randomised controlled trial comparing gastric tube insertion for the Laryngeal Mask Airway Flexible.
Region
Japan

Condition
Condition patients undergoing otological surgery
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 compareing LMA flexible inserted gastric tube with LMA flexible only.
Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes success of LMA insertion
Key secondary outcomes expiratoly volume
sore troat
gastric fluid
fibreoptic score

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking YES
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 gastric tube insertion
Interventions/Control_2 none
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
100 years-old >
Gender Male and Female
Key inclusion criteria Patients undergoing otological surgery
Key exclusion criteria BMI>25
patients who refuse

Patients who underwent pharyngeal surgery or radiation therapy

Patients who underwent esophageal or gastric surgery
Target sample size 50

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Manabu Yoshimura
Organization Japan Community Healthcare Organization Tokuyama Central Hospital
Division name Anesthesiology
Zip code
Address Koda-cho 1-1 Shunan, 745-8522 Japan
TEL 0834-22-4411
Email manabu-ygc@umin.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Manabu Yoshimura
Organization Japan Community Healthcare Organization Tokuyama Central Hospital
Division name Anesthesiology
Zip code
Address Koda-cho 1-1 Shunan, 745-8522 Japan
TEL 0834-22-4411
Homepage URL
Email manabu-ygc@umin.ac.jp

Sponsor
Institute Japan Community Healthcare Organization Tokuyama Central Hospital
Institute
Department

Funding Source
Organization Japan Community Healthcare Organization Tokuyama Central Hospital
Organization
Division
Category of Funding Organization Self funding
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 04 Month 11 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 Enrolling by invitation
Date of protocol fixation
2016 Year 04 Month 11 Day
Date of IRB
Anticipated trial start date
2016 Year 04 Month 11 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 04 Month 11 Day
Last modified on
2016 Year 04 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025206

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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