UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026000 |
|---|---|
| Receipt number | R000029890 |
| Scientific Title | Examination of effectiveness of airway assessment method predicting difficulty of intubation |
| Date of disclosure of the study information | 2017/02/28 |
| Last modified on | 2017/02/17 14:38:32 |
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Basic information
Public title
Examination of effectiveness of airway assessment method predicting difficulty of intubation
Acronym
Prediction of tracheal intubation difficulty levels
Scientific Title
Examination of effectiveness of airway assessment method predicting difficulty of intubation
Scientific Title:Acronym
Prediction of tracheal intubation difficulty levels
Region
| Japan |
Condition
Condition
Patients undergoing general anesthesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
There are many airway evaluation items at the bed side before surgery, but there is no item with high reliability that can predict intubation difficulties by itself.Therefore, we examined whether there was a high precision preoperative examination that could predict intubation difficulty more easily with a few preoperative examination items.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
After introduction of general anesthesia, laryngeal deployment was performed using the laryngoscope, and laryngeal findings were evaluated using Cormack-Lehane classification.
Key secondary outcomes
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
| 16 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients scheduled to undergo general anesthesia
Key exclusion criteria
15 years old or younger, malformation of face / neck, pregnant woman
Target sample size
480
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshino Kazuhisa |
Organization
Kitasato University School of Medicine
Division name
Anesthesiology
Zip code
Address
Kitasato 1-15-1 minamiku Sagamihara city Kanagawa
TEL
0427788111
yoshinokazuhisa0906@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshino Kazuhisa |
Organization
Kitasato University School of Medicine
Division name
Anesthesiology
Zip code
Address
Kitasato 1-15-1 minamiku Sagamihara city Kanagawa
TEL
0427788111
Homepage URL
yoshinokazuhisa0906@yahoo.co.jp
Sponsor or person
Institute
Kitasato University School
Institute
Department
Personal name
Funding Source
Organization
none
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
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
| 2017 | Year | 02 | Month | 28 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Completed
Date of protocol fixation
| 2011 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 09 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 02 | Month | 04 | Day |
Last modified on
| 2017 | Year | 02 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029890
