UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study of proper tracheal tube fixed with Fiber scope in children
Title of the study (Brief title)	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	Tsukamoto Masanori
Organization	Kyushu university hospital
Division name	Department of dental anesthesiology
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	Tsukamoto Masanori
Organization	Kyushu university hospital
Division name	Department of dental anesthesiology
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)

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

Progress
Recruitment status	Main results already published
Date of protocol fixation	2016 Year 05 Month 31 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000026796