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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000038887
Receipt No. R000044343
Scientific Title Assessment of view of the glottis and the arytenoids for different types of supraglottic airway devices under general anesthesia during medialization laryngoplasty
Date of disclosure of the study information 2019/12/16
Last modified on 2019/12/14

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Basic information
Public title Assessment of view of the glottis and the arytenoids for different types of supraglottic airway devices under general anesthesia during medialization laryngoplasty
Acronym Assessment of view of the glottis and the arytenoids for different types of supraglottic airway devices during medialization laryngoplasty
Scientific Title Assessment of view of the glottis and the arytenoids for different types of supraglottic airway devices under general anesthesia during medialization laryngoplasty
Scientific Title:Acronym Assessment of view of the glottis and the arytenoids for different types of supraglottic airway devices during medialization laryngoplasty
Region
Japan

Condition
Condition Unilateral vocal fold paralysis
Classification by specialty
Oto-rhino-laryngology Anesthesiology Operative medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We will examine the supraglottic airway device that can obtain the best surgical field from three types of supraglottic devices (i-gel, Supreme, Aura Gain) in medialization laryngoplasty.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The view of the glottis and arytenoids through the supraglottic airway device. (We will create scoring system.)
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 After induction of anesthesia, we will insert supraglottic airway device (i-gel) and evaluate view of the glottis and the arytenoids with a bronchoscope.
Interventions/Control_2 After induction of anesthesia, we will insert supraglottic airway device (Supreme) and evaluate view of the glottis and the arytenoids with a bronchoscope.
Interventions/Control_3 After induction of anesthesia, we will insert supraglottic airway device (Auragain) and evaluate view of the glottis and the arytenoids with a bronchoscope.
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 1. Patients over 20 years old.
2. Patients who have received sufficient explanation and written consent.
3. A person who has been given sufficient explanation and a written consent has been obtained if the participant does not have the consent ability.
Key exclusion criteria 1. Patients who have trims.
2. Patients who have risk of aspiration.
3. Malposition of supraglottic airway device.
4. Patients who are judged to be inappropriate as subjects by the principal investigator.
Target sample size 15

Research contact person
Name of lead principal investigator
1st name Yuki
Middle name
Last name Maruyama
Organization Shinshu university school of medicine
Division name The Department of anesthesiology and resuscitology
Zip code 390-8621
Address 3-1-1 Asahi, Matsumoto city, Nagano
TEL 0263-37-2670
Email y5maruyama@shinshu-u.ac.jp

Public contact
Name of contact person
1st name Yuki
Middle name
Last name Maruyama
Organization Shinshu university school of medicine
Division name The Department of anesthesiology and resuscitology
Zip code 390-8621
Address 3-1-1 Asahi, Matsumoto city, Nagano
TEL 0263-37-2670
Homepage URL
Email y5maruyama@shinshu-u.ac.jp

Sponsor
Institute Shinshu University
Institute
Department

Funding Source
Organization none
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 The Department of anesthesiology and resuscitology, shinshu university school of medicine
Address 3-1-1 Asahi, Matsumoto city, Nagano
Tel 0263-37-2670
Email y5maruyama@shinshu-u.ac.jp

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
2019 Year 12 Month 16 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 Preinitiation
Date of protocol fixation
2019 Year 12 Month 16 Day
Date of IRB
Anticipated trial start date
2019 Year 12 Month 16 Day
Last follow-up date
2024 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
2019 Year 12 Month 14 Day
Last modified on
2019 Year 12 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044343

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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