UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038887 |
|---|---|
| Receipt number | 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 | 2022/11/24 17:09:02 |
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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
Cross-over
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
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
y5maruyama@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University
Institute
Department
Personal name
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
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
Open public recruiting
Date of protocol fixation
| 2019 | Year | 12 | Month | 16 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 10 | Day |
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
| 2022 | Year | 11 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044343
