UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030627 |
|---|---|
| Receipt number | R000033987 |
| Scientific Title | The effect of order made simulator and simulation for the children who had difficult airway |
| Date of disclosure of the study information | 2017/12/28 |
| Last modified on | 2019/07/02 12:23:45 |
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Basic information
Public title
The effect of order made simulator and simulation for the children who had difficult airway
Acronym
The effect of order made simulator and simulation for the children who had difficult airway
Scientific Title
The effect of order made simulator and simulation for the children who had difficult airway
Scientific Title:Acronym
The effect of order made simulator and simulation for the children who had difficult airway
Region
| Japan |
Condition
Condition
difficult airway
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Make a order made simulator from head and neck CT for the children who had difficult airway. Then we do preoperative simulation of intubation (bag mask and intubation), and make a intubation strategy for the children for the time of anesthesia. After children receive anesthesia and operation, we evaluate the utility of preoperative simulation of intubation using the order made simulator
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The effect of order made simulator
1 the differentiation of bag and mask
2 the differentiation of Cormack between patient and simulator
3 the differentiation of the view of video laryngoscopy
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
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
CT
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
| Not applicable |
Age-upper limit
| 16 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The patients who had difficult intubation
Key exclusion criteria
The patients who diagnosed non difficult airway after anesthesia
Target sample size
7
Research contact person
Name of lead principal investigator
| 1st name | TOMOYUKI |
| Middle name | |
| Last name | KANAZAWA |
Organization
Okayama University Hospital
Division name
Intensive Care Unit
Zip code
700-8558
Address
2-5-1, Shikata-cho, Kita-ku, Okayama city
TEL
086-235-7778
tyskanazawa@gmail.com
Public contact
Name of contact person
| 1st name | YUKO |
| Middle name | |
| Last name | MIHARA |
Organization
Okayama University
Division name
Anesthesiology and Resuscitology
Zip code
7008558
Address
2-5-1, Shikata-cho, Kita-ku, Okayama city
TEL
086-235-7778
Homepage URL
mihara@cc.okayama-u.ac.jp
Sponsor or person
Institute
Okayama University
Institute
Department
Personal name
Funding Source
Organization
Japanese Society of Anesthesiologists
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
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences and Okayama University Hospital, Ethics Committee
Address
2-5-1, Shikata-cho, Kita-ku, Okayama city
Tel
0862356938
mae6605@adm.okayama-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
岡山大学病院（岡山県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 12 | Month | 28 | 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
| 2018 | Year | 01 | Month | 16 | Day |
Date of IRB
| 2018 | Year | 01 | Month | 16 | Day |
Anticipated trial start date
| 2018 | Year | 01 | Month | 17 | Day |
Last follow-up date
| 2021 | Year | 10 | 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
| 2017 | Year | 12 | Month | 28 | Day |
Last modified on
| 2019 | Year | 07 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033987
