UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021863 |
|---|---|
| Receipt number | 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 | 2021/04/19 09:09:13 |
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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
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
manabu-ygc@umin.ac.jp
Public contact
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
manabu-ygc@umin.ac.jp
Sponsor or person
Institute
Japan Community Healthcare Organization Tokuyama Central Hospital
Institute
Department
Personal name
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
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
Completed
Date of protocol fixation
| 2016 | Year | 04 | Month | 11 | Day |
Date of IRB
| 2016 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2016 | Year | 04 | Month | 11 | Day |
Last follow-up date
| 2018 | 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
| 2016 | Year | 04 | Month | 11 | Day |
Last modified on
| 2021 | Year | 04 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025206
