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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000002161
Receipt No. R000002644
Scientific Title Multivariable analysis in factors of difficult intubation using AirWay Scope
Date of disclosure of the study information 2009/07/03
Last modified on 2012/02/27

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Basic information
Public title Multivariable analysis in factors of difficult intubation using AirWay Scope
Acronym Multivariable analysis in factors of difficult intubation using AirWay Scope
Scientific Title Multivariable analysis in factors of difficult intubation using AirWay Scope
Scientific Title:Acronym Multivariable analysis in factors of difficult intubation using AirWay Scope
Region
Japan

Condition
Condition All diseases requiring non-emergency operaiton with general anesthesia
Classification by specialty
Surgery in general Gastrointestinal surgery Hepato-biliary-pancreatic surgery
Vascular surgery Chest surgery Endocrine surgery
Breast surgery Oto-rhino-laryngology Orthopedics
Urology Neurosurgery Cardiovascular surgery
Plastic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The AirWay Scope (AWS) is recently developed indirect laryngoscopy, which is useful in the difficult airway management. However, difficult intubation still remains despite of the use of the AWS. We conduct this study to identify factors of difficult intubation when the AWS used.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes We evaluate Mallampati classification, thyro-mental distance, sterno-mental distance, upper lip bite test. We also evaluate laryngeal view by Cormack & Lahane grade with Macintosh laryngoscope. Thereafter, we record the glottic view during intubation with AWS on videotape.
Key secondary outcomes Find significant factor attributing difficult intubation with AWS using Multivariable analysis.

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 Patients who undergo general anesthesia with tracheal intubation.
Key exclusion criteria The patients who are apparently anticipated difficult intubation and the patient of ASA physical status more than III.
Target sample size 500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Koichi Maruyama
Organization International Medical Center, Saitama Medical University
Division name Department of Anesthesiology
Zip code
Address 1397-1 Yamane, Hidaka, Saitama, JAPAN
TEL 042-984-4111
Email

Public contact
Name of contact person
1st name
Middle name
Last name Koichi Maruyama
Organization International Medical Center, Saitama Medical University
Division name Department of Anesthesiology
Zip code
Address 1397-1 Yamane, Hidaka, Saitama, JAPAN
TEL
Homepage URL
Email

Sponsor
Institute International Medical Center, Saitama Medical University
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
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

Other administrative information
Date of disclosure of the study information
2009 Year 07 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
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 Terminated
Date of protocol fixation
2009 Year 08 Month 03 Day
Date of IRB
Anticipated trial start date
2009 Year 08 Month 01 Day
Last follow-up date
2010 Year 08 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Preoperative evaluation of Mallampati classification, thyro-mental distance, sterno-mental distance, upper lip bite test.
Evaluation of glottic visualization of glottis with Macintosh laryngoscopy.
Recording and evaluation of difficulty of threading tracheal tube during intubation with the AWS.

Management information
Registered date
2009 Year 07 Month 03 Day
Last modified on
2012 Year 02 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002644

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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