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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000030627
Receipt No. 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

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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
Email 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
Email mihara@cc.okayama-u.ac.jp

Sponsor
Institute Okayama University
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033987

Research Plan
Registered date File name
2018/12/29 rk..keikaku挿管困難シミュレーション研究計画書new.docx

Research case data specifications
Registered date File name

Research case data
Registered date File name


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