UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019039 |
|---|---|
| Receipt number | R000020726 |
| Scientific Title | Evaluation of tracehal tube passage difficulty for tracehal intubation |
| Date of disclosure of the study information | 2015/09/16 |
| Last modified on | 2016/10/07 22:28:57 |
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Basic information
Public title
Evaluation of tracehal tube passage difficulty for tracehal intubation
Acronym
Tracehal tube pssaga difficulty for airway management
Scientific Title
Evaluation of tracehal tube passage difficulty for tracehal intubation
Scientific Title:Acronym
Tracehal tube pssaga difficulty for airway management
Region
| Japan |
Condition
Condition
Patient sho undergo general anesthesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evluation of correlation of intubation difficulty or postoperative complication with tracehal tube passage difficulty.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relationship with other intubation related points
Key secondary outcomes
Correlation with postoperative pharyngeal pain or hoarseness
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
| 20 | years-old | <= |
Age-upper limit
| 85 | years-old | > |
Gender
Male
Key inclusion criteria
Patient who undergo general anesthesia
Key exclusion criteria
Cases not applicable for Macintosh laryngoscope
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshiaki Minami |
Organization
Osaka Medical college
Division name
Anesthesiology
Zip code
Address
2-7 Daigaku-machi, Takatsuk city
TEL
0726-84-6361
ane022@poh.osaka-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nobuyasu Komasawa |
Organization
Osaka Medical College
Division name
Anesthesiology
Zip code
Address
2-7Daigaku-machi, Takatsuki city
TEL
0726-84-6361
Homepage URL
ane078@osaka-med.ac.jp
Sponsor or person
Institute
Osaka Medical College
Institute
Department
Personal name
Funding Source
Organization
Osaka Medical College
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
| 2015 | Year | 09 | Month | 16 | 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
By univariate analysis, hoarseness were significantly associated with number of tracheal intubation and resistance for tracheal tube passage (P<0.001). In a multivariate logistic regression that adjusted for known or potential effects on hoarseness, the association between number of tracheal intubation and hoarseness was no longer apparent. The resistance for tracheal tube passage was the only independently associated with hoarseness (P<0.001).
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
| 2015 | Year | 09 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 09 | Month | 17 | Day |
Last follow-up date
| 2016 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2016 | Year | 10 | Month | 07 | Day |
Date trial data considered complete
| 2016 | Year | 10 | Month | 08 | Day |
Date analysis concluded
Other
Other related information
1Preoperative airway evaluation
mouth opening, Mallampati, laryngeal deviation, tooth disorder.
2Factors associated with tracheal intubation
Number of tracheal intubation, number of laryngoscopy, tracheal intubation resistance.
Evaluating the predictive factors for postoperative hoarseness or pharyngeal pain associated with NO1 and NO2
Management information
Registered date
| 2015 | Year | 09 | Month | 16 | Day |
Last modified on
| 2016 | Year | 10 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020726
