UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Examination of effectiveness of airway assessment method predicting difficulty of intubation
Title of the study (Brief title)	Prediction of tracheal intubation difficulty levels
Region	Japan

Condition
Condition	Patients undergoing general anesthesia
Classification by specialty	Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	There are many airway evaluation items at the bed side before surgery, but there is no item with high reliability that can predict intubation difficulties by itself.Therefore, we examined whether there was a high precision preoperative examination that could predict intubation difficulty more easily with a few preoperative examination items.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	After introduction of general anesthesia, laryngeal deployment was performed using the laryngoscope, and laryngeal findings were evaluated using Cormack-Lehane classification.
Key secondary outcomes

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	16 years-old <=
Age-upper limit	100 years-old >
Gender	Male and Female
Key inclusion criteria	Patients scheduled to undergo general anesthesia
Key exclusion criteria	15 years old or younger, malformation of face / neck, pregnant woman
Target sample size	480

Research contact person
Name of lead principal investigator	Yoshino Kazuhisa
Organization	Kitasato University School of Medicine
Division name	Anesthesiology
Address	Kitasato 1-15-1 minamiku Sagamihara city Kanagawa
TEL	0427788111
Email	yoshinokazuhisa0906@yahoo.co.jp

Public contact
Name of contact person	Yoshino Kazuhisa
Organization	Kitasato University School of Medicine
Division name	Anesthesiology
Address	Kitasato 1-15-1 minamiku Sagamihara city Kanagawa
TEL	0427788111
Homepage URL
Email	yoshinokazuhisa0906@yahoo.co.jp

Sponsor
Institute	Kitasato University School
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	2017 Year 02 Month 28 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 09 Month 01 Day
Anticipated trial start date	2013 Year 09 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	Published
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 02 Month 04 Day
Last modified on	2017 Year 02 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000029890