UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023258 |
|---|---|
| Receipt number | 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 15:37:30 |
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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
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
tsukamoto@dent.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu university
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026796
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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