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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000023258
Receipt No. R000026796
Scientific Title Study of proper tracheal tube fixed with Fiber scope in children
Date of disclosure of the study information 2016/07/21
Last modified on 2018/09/11

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Basic information
Public title Study of proper tracheal tube fixed with Fiber scope in children
Acronym Study of proper tracheal tube fixed with Fiber scope in children
Scientific Title Study of proper tracheal tube fixed with Fiber scope in children
Scientific Title:Acronym Study of proper tracheal tube fixed with Fiber scope in children
Region
Japan

Condition
Condition Pediatric patients to perform general anesthesia
Classification by specialty
Anesthesiology Dental medicine Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The tracheal tube when performing a nasal intubation of children is fixed at an appropriate position by bronchial fiber. Then, measure the distance for the position change of the tracheal tube tip when changing the position of the head, performing the study
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes Measuring the distance of from tracheal tube tip to the nasal cavity, glottis, the tracheal bifurcation by changing the angle of the head(80 degrees, 110 degrees, 130 degrees).
Key secondary outcomes 1.Tube size
2.Patient back ground (sex, height, weight, BMI, history, chest X-ray)

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
2 years-old <=
Age-upper limit
15 years-old >=
Gender Male and Female
Key inclusion criteria Patients that will be managed the general anesthesia in a nasal intubation
Key exclusion criteria 1.Severe heart failure patient
2.Severe respiratory disease patient
3.Uncommunicated patient
4.Intubation difficult patient
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tsukamoto Masanori
Organization Kyushu university hospital
Division name Department of dental anesthesiology
Zip code
Address Higashi-ku, Fukuoka Maidashi 3-1-1
TEL 092-642-6480
Email tsukamoto@dent.kyushu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tsukamoto Masanori
Organization Kyushu university hospital
Division name Department of dental anesthesiology
Zip code
Address Higashi-ku, Fukuoka Maidashi 3-1-1
TEL 092-642-6480
Homepage URL
Email tsukamoto@dent.kyushu-u.ac.jp

Sponsor
Institute Kyushu university
Institute
Department

Funding Source
Organization Kyushu university
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
Address
Tel
Email

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 07 Month 21 Day

Related information
URL releasing protocol
Publication of results Published

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 Main results already published
Date of protocol fixation
2016 Year 05 Month 31 Day
Date of IRB
Anticipated trial start date
2016 Year 07 Month 20 Day
Last follow-up date
2021 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information no special instruction

Management information
Registered date
2016 Year 07 Month 20 Day
Last modified on
2018 Year 09 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026796

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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