UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of tracehal tube passage difficulty for tracehal intubation
Title of the study (Brief title)	Tracehal tube pssaga difficulty for airway management
Region	Japan

Condition
Condition	Patient sho undergo general anesthesia
Classification by specialty	Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Evluation of correlation of intubation difficulty or postoperative complication with tracehal tube passage difficulty.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Relationship with other intubation related points
Key secondary outcomes	Correlation with postoperative pharyngeal pain or hoarseness

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	20 years-old <=
Age-upper limit	85 years-old >
Gender	Male
Key inclusion criteria	Patient who undergo general anesthesia
Key exclusion criteria	Cases not applicable for Macintosh laryngoscope
Target sample size	500

Research contact person
Name of lead principal investigator	Toshiaki Minami
Organization	Osaka Medical college
Division name	Anesthesiology
Address	2-7 Daigaku-machi, Takatsuk city
TEL	0726-84-6361
Email	ane022@poh.osaka-med.ac.jp

Public contact
Name of contact person	Nobuyasu Komasawa
Organization	Osaka Medical College
Division name	Anesthesiology
Address	2-7Daigaku-machi, Takatsuki city
TEL	0726-84-6361
Homepage URL
Email	ane078@osaka-med.ac.jp

Sponsor
Institute	Osaka Medical College
Institute
Department

Funding Source
Organization	Osaka Medical College
Organization
Division
Category of Funding Organization	Self funding
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 09 Month 16 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 09 Month 07 Day
Anticipated trial start date	2015 Year 09 Month 17 Day
Last follow-up date	2016 Year 09 Month 30 Day
Date of closure to data entry	2016 Year 10 Month 07 Day
Date trial data considered complete	2016 Year 10 Month 08 Day
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results	By univariate analysis, hoarseness were significantly associated with number of tracheal intubation and resistance for tracheal tube passage (P<0.001). In a multivariate logistic regression that adjusted for known or potential effects on hoarseness, the association between number of tracheal intubation and hoarseness was no longer apparent. The resistance for tracheal tube passage was the only independently associated with hoarseness (P<0.001).
Other related information	1Preoperative airway evaluation mouth opening, Mallampati, laryngeal deviation, tooth disorder. 2Factors associated with tracheal intubation Number of tracheal intubation, number of laryngoscopy, tracheal intubation resistance. Evaluating the predictive factors for postoperative hoarseness or pharyngeal pain associated with NO1 and NO2

Management information
Registered date	2015 Year 09 Month 16 Day
Last modified on	2016 Year 10 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020726