UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A comparison of laryngoscopic views: "head and neck elevation" and "Anespillow (optimized pillow for intubation)" position
Title of the study (Brief title)	Anespillow research
Region	Japan

Condition
Condition	Surgery patients who need tracheal intubation
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The research of "Anespillow (optimized pillow for intubation)" for tracheal intubation
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Cormack grade POGO(percentage of glottis opening) score Dulation of intubation time Damage to the soft tissue
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	Pseudo-randomization

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	normal pillow and anespillow
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	adult surgery patients who need tracheal intubation
Key exclusion criteria	surgery patients who do not need tracheal intubation
Target sample size	120

Research contact person
Name of lead principal investigator	Maiko Satomoto
Organization	Tokyo Medical and Dental University
Division name	Anesthesiology
Address	1-5-34 Yushima, Bunkyo-ku, Tokyo
TEL	03-5803-5325
Email	satomoto.mane@tmd.ac.jp

Public contact
Name of contact person	Maiko Satomoto
Organization	Tokyo Medical and Dental University
Division name	Anesthesiology
Address	1-5-34 Yushima, Bunkyo-ku, Tokyo
TEL	03-5803-5325
Homepage URL
Email	satomoto.mane@tmd.ac.jp

Sponsor
Institute	Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization	Tokyo Medical and Dental University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

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	東京医科歯科大学医学部附属病院

Other administrative information
Date of disclosure of the study information	2016 Year 03 Month 31 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 02 Month 22 Day
Anticipated trial start date	2016 Year 07 Month 05 Day
Last follow-up date	2016 Year 12 Month 20 Day
Date of closure to data entry	2016 Year 12 Month 20 Day
Date trial data considered complete	2016 Year 12 Month 20 Day
Date analysis concluded	2016 Year 12 Month 20 Day

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

Management information
Registered date	2016 Year 02 Month 23 Day
Last modified on	2016 Year 12 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024410