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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000033456
Receipt No. R000038150
Scientific Title A randomized crossover comparison of the MultiViewScope handle with a stylet scope to the Miller blade direct laryngoscopy in manikins simulating normal and difficult pediatric airways
Date of disclosure of the study information 2018/07/20
Last modified on 2019/04/30

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Basic information
Public title A randomized crossover comparison of the MultiViewScope handle with a stylet scope to the Miller blade direct laryngoscopy in manikins simulating normal and difficult pediatric airways
Acronym A comparison of the MultiViewScope handle with a stylet scope to the direct laryngoscopy in normal and difficult pediatric airways
Scientific Title A randomized crossover comparison of the MultiViewScope handle with a stylet scope to the Miller blade direct laryngoscopy in manikins simulating normal and difficult pediatric airways
Scientific Title:Acronym A comparison of the MultiViewScope handle with a stylet scope to the direct laryngoscopy in normal and difficult pediatric airways
Region
Japan

Condition
Condition The normal and difficult pediatric airways
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of the MultiViewScope handle with a stylet scope in pediatric airways.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The time to inubation
Key secondary outcomes The success rate, the number of tracheal intubation attempts, the Cormack & Lehane grades scored by participants, the difficulty of tracheal intubation using Numerical Rating Scale (0 = very easy and 10 = very difficult) scored by participants, and the pressure applied to the maxilla

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 The MultiViewScope handle with a stylet scope
Interventions/Control_2 The Miller blade direct laryngoscopy
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
18 years-old <=
Age-upper limit
70 years-old >=
Gender Male and Female
Key inclusion criteria The Japanese Society of Anesthesiologists Board Certified Anesthesiologist, or the anesthesia residents
Key exclusion criteria None
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Kohei
Middle name
Last name Godai
Organization Graduate School of Medical and Dental Sciences, Kagoshima University
Division name Department of Anesthesiology and Critical Care Medicine
Zip code 8908520
Address 8-35-1 Sakuragaoka, Kagoshima 890-8520, Japan
TEL +81992755430
Email kxg179@icloud.com

Public contact
Name of contact person
1st name Kohei
Middle name
Last name Godai
Organization Graduate School of Medical and Dental Sciences, Kagoshima University
Division name Department of Anesthesiology and Critical Care Medicine
Zip code 8908520
Address 8-35-1 Sakuragaoka, Kagoshima 890-8520, Japan
TEL +81992755430
Homepage URL
Email kxg179@icloud.com

Sponsor
Institute Graduate School of Medical and Dental Sciences, Kagoshima University
Institute
Department

Funding Source
Organization Graduate School of Medical and Dental Sciences, Kagoshima University
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 Ethics Committee on Epidemiological Studies, Kagoshima University
Address 8-35-1 Sakuragaoka, Kagoshima 890-8520, Japan
Tel +81992755111
Email isgskkrs@kuas.kagoshima-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
2018 Year 07 Month 20 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 07 Month 20 Day
Date of IRB
2017 Year 07 Month 20 Day
Anticipated trial start date
2018 Year 07 Month 20 Day
Last follow-up date
2020 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
2018 Year 07 Month 20 Day
Last modified on
2019 Year 04 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038150

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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