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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000017790
Receipt No. R000020604
Scientific Title Incidence and Predictors of Difficult Mask Ventilation and Difficult Laryngoscopy, A Study of Preoperative Airway Evaluation.
Date of disclosure of the study information 2015/06/03
Last modified on 2018/06/05

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Basic information
Public title Incidence and Predictors of Difficult Mask Ventilation and Difficult Laryngoscopy, A Study of Preoperative Airway Evaluation.
Acronym Incidence and Predictors of DMV and DLS, A Study of Preoperative Airway Evaluation.
Scientific Title Incidence and Predictors of Difficult Mask Ventilation and Difficult Laryngoscopy, A Study of Preoperative Airway Evaluation.
Scientific Title:Acronym 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
1st name
Middle name
Last name Hiroshi Yamashita
Organization Kobe city medical center general hospital
Division name Department of anesthesiology
Zip code
Address Minatojimaminamimachi2-1-1 chuou-ku Kobe city, Japan
TEL 078-302-4321
Email cantateveritas@kcho.jp

Public contact
Name of contact person
1st name
Middle name
Last name HIroshi Yamashita
Organization Kobe city medical center general hospital
Division name Department of anesthesiology
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results risk factors of difficult mask ventilation and difficult intubation were identified: male,age>51,bmi>25,snoring,osas,receding mandibular,neck flexion restricted.
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Main results already published
Date of protocol fixation
2015 Year 06 Month 03 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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