UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002161 |
|---|---|
| Receipt number | 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 19:41:26 |
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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
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
Sponsor or person
Institute
International Medical Center, Saitama Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002644
