UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017790 |
|---|---|
| Receipt number | 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 10:32:46 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
cantateveritas@kcho.jp
Sponsor or person
Institute
Kobe city medical center general hospital, Department of anesthesiology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020604
