UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A comparison of insertion depth of pediatric cuffed endotracheal tubes determined by intubation depth marks
Title of the study (Brief title)	Appropriateness of intubation depth marks of pediatric cuffed endotracheal tubes
Region	Japan

Condition
Condition	Infants and small children requring general anesthesia and postoperative chestradiography
Classification by specialty	Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purposes of the present study are to reveal factors associated with optimal insertion depth of pediatric cuffed endotracheal tubes in comparison of intubation depth marks between conventional pediatric cuffed endotracheal tubes and the new one and to make a novel formula to predict optimal insertion depth of endotracheal tubes alleviating risks for intubated pediatric patients.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	After intubation of pediatric cuffed endotracheal tubes by direct laryngoscopy and cheking by auscultation and capnography, the tip of tubes is investigated by chestradiography.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Microcuff-PET group
Interventions/Control_2	Mallinckrodt group
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	12 years-old >
Gender	Male and Female
Key inclusion criteria	Infants and small children requring general anesthesia and postoperative chestradiography
Key exclusion criteria	Exclusion criteria are emergency surgery, known or anticipated difficult intubation and ASA physical status >III
Target sample size	100

Research contact person
Name of lead principal investigator	Teiji Sawa
Organization	Kyoto Prefectural University of Medicine
Division name	Anesthesiology
Address	465 Kajii-cho, Kamigyo-ku, Kyoto 602-8566, japan
TEL	0752515633
Email	anesth@koto.kpu-m.ac.jp

Public contact
Name of contact person	Masayuki Sibasaki
Organization	Kyoto Prefectural University of Medicine
Division name	Anesthesiology
Address	465 Kajii-cho, Kamigyo-ku, Kyoto 602-8566, japan
TEL	0752515633
Homepage URL
Email	mshiba@koto.kpu-m.ac.jp

Sponsor
Institute	Kyoto Prefectural University of Medicine
Institute
Department

Funding Source
Organization	none
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	2015 Year 01 Month 25 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 02 Month 01 Day
Anticipated trial start date	2015 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 01 Month 24 Day
Last modified on	2018 Year 03 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018944