UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Incidence and Predictors of Difficult Mask Ventilation and Difficult Laryngoscopy, A Study of Preoperative Airway Evaluation.
Title of the study (Brief title)	Incidence and Predictors of DMV and DLS, A Study of Preoperative Airway Evaluation.
Region	Japan

Condition
Condition	Airway Management of General Anesthesia Induction
Classification by specialty	Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The techniques of mask ventilation and intubation complement each other. Airway evaluation has been focused on difficult intubation.In 2013 multicenter study has been published in US.We tried to verify the validity of the 12 preoperative evaluation items to target the Japanese patients.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Incidence and Predictors of Difficult Mask Ventilation combined with Difficult Laryngoscopy
Key secondary outcomes	Incidence and Predictors of DMV, Incidence and Predictors of DLS, Rescue airway management techniques, Incidence and Airway Management of JSA-AMA Yellow zone

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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Adult patients who had undergone surgery under general anesthesia started by rapid introduction at our hospital.
Key exclusion criteria	Patients who had'nt been undergone mask ventilation during anesthesia induction, patients who had been planned awake intubation from the beginning, patients who had been planned to use supraglottic device from the beginning.
Target sample size	12000

Research contact person
Name of lead principal investigator	Hiroshi Yamashita
Organization	Kobe city medical center general hospital
Division name	Department of anesthesiology
Address	Minatojimaminamimachi2-1-1 chuou-ku Kobe city, Japan
TEL	078-302-4321
Email	cantateveritas@kcho.jp

Public contact
Name of contact person	HIroshi Yamashita
Organization	Kobe city medical center general hospital
Division name	Department of anesthesiology
Address	Minatojimaminamimachi2-1-1 chuou-ku Kobe city, Japan
TEL	078-302-4321
Homepage URL
Email	cantateveritas@kcho.jp

Sponsor
Institute	Kobe city medical center general hospital, Department of anesthesiology
Institute
Department

Funding Source
Organization	no fund
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	神戸市立医療センター中央市民病院（兵庫県）

Other administrative information
Date of disclosure of the study information	2015 Year 06 Month 03 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2015 Year 06 Month 03 Day
Anticipated trial start date	2015 Year 06 Month 03 Day
Last follow-up date	2015 Year 12 Month 03 Day
Date of closure to data entry	2015 Year 12 Month 03 Day
Date trial data considered complete	2015 Year 12 Month 03 Day
Date analysis concluded	2015 Year 12 Month 03 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results	risk factors of difficult mask ventilation and difficult intubation were identified: male,age>51,bmi>25,snoring,osas,receding mandibular,neck flexion restricted.
Other related information	Main results were presented at Japan Society of Anesthesiology annual meeting, 2015.

Management information
Registered date	2015 Year 06 Month 03 Day
Last modified on	2018 Year 06 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020604