UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021168 |
|---|---|
| Receipt number | R000024410 |
| Scientific Title | A comparison of laryngoscopic views: "head and neck elevation" and "Anespillow (optimized pillow for intubation)" position |
| Date of disclosure of the study information | 2016/03/31 |
| Last modified on | 2016/12/20 14:31:18 |
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Basic information
Public title
A comparison of laryngoscopic views: "head and neck elevation" and "Anespillow (optimized pillow for intubation)" position
Acronym
Anespillow research
Scientific Title
A comparison of laryngoscopic views: "head and neck elevation" and "Anespillow (optimized pillow for intubation)" position
Scientific Title:Acronym
Anespillow research
Region
| Japan |
Condition
Condition
Surgery patients who need tracheal intubation
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The research of "Anespillow (optimized pillow for intubation)" for tracheal intubation
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Cormack grade
POGO(percentage of glottis opening) score
Dulation of intubation time
Damage to the soft tissue
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Pseudo-randomization
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
normal pillow and anespillow
Interventions/Control_2
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
adult surgery patients who need tracheal intubation
Key exclusion criteria
surgery patients who do not need tracheal intubation
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Maiko Satomoto |
Organization
Tokyo Medical and Dental University
Division name
Anesthesiology
Zip code
Address
1-5-34 Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-5325
satomoto.mane@tmd.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Maiko Satomoto |
Organization
Tokyo Medical and Dental University
Division name
Anesthesiology
Zip code
Address
1-5-34 Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-5325
Homepage URL
satomoto.mane@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Medical and Dental University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
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
東京医科歯科大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 03 | Month | 31 | 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 | 02 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 07 | Month | 05 | Day |
Last follow-up date
| 2016 | Year | 12 | Month | 20 | Day |
Date of closure to data entry
| 2016 | Year | 12 | Month | 20 | Day |
Date trial data considered complete
| 2016 | Year | 12 | Month | 20 | Day |
Date analysis concluded
| 2016 | Year | 12 | Month | 20 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 02 | Month | 23 | Day |
Last modified on
| 2016 | Year | 12 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024410
