UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022136 |
|---|---|
| Receipt number | R000025514 |
| Scientific Title | Evaluation of the maximum force onto the maxillary incisors and cervical spine motion during endotracheal intubation using simulator. Comparison by anesthetic experience or by types of laryngoscope. |
| Date of disclosure of the study information | 2016/05/01 |
| Last modified on | 2016/10/30 10:45:11 |
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Basic information
Public title
Evaluation of the maximum force onto the maxillary incisors and cervical spine motion during endotracheal intubation using simulator. Comparison by anesthetic experience or by types of laryngoscope.
Acronym
Evaluation of the maximum force onto the maxillary incisors and cervical spine motion during endotracheal intubation using simulator.
Scientific Title
Evaluation of the maximum force onto the maxillary incisors and cervical spine motion during endotracheal intubation using simulator. Comparison by anesthetic experience or by types of laryngoscope.
Scientific Title:Acronym
Evaluation of the maximum force onto the maxillary incisors and cervical spine motion during endotracheal intubation using simulator.
Region
| Japan |
Condition
Condition
tracheal intubation
Classification by specialty
| Anesthesiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is measuring the force onto the maxillary incisors and the cervical spine motion and comparison by anesthetic experience or by types of laryngoscope in simulation settings.
Basic objectives2
Others
Basic objectives -Others
The aim of this study is measuring the force onto the maxillary incisors and the cervical spine motion and comparison by anesthetic experience or by types of laryngoscope in simulation settings.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
force onto the maxillary incisors during endotracheal intubation
Key secondary outcomes
cervical spine motion during endotracheal intubation
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
anesthesiologists who can intubate with direct laryngoscope and video laryngoscope
Key exclusion criteria
in case of esophageal intubation
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hitoshi Sato |
Organization
Yokohama City University Graduate School of Medical Sciences and School of Medicine
Division name
Department of Anesthesiology
Zip code
Address
3-9 Fuku-ura, Kanazawa-ku, Yokohama 236-0004, JAPAN
TEL
045-787-2918
sjinkun@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hitoshi Sato |
Organization
Yokohama City University Graduate School of Medical Sciences and School of Medicine
Division name
Department of Anesthesiology
Zip code
Address
3-9 Fuku-ura, Kanazawa-ku, Yokohama 236-0004, JAPAN
TEL
045-787-2918
Homepage URL
sjinkun@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University Graduate School of Medical Sciences and School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Yokohama City University Graduate School of Medical Sciences and School of Medicine
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
| 2016 | Year | 05 | Month | 01 | 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
Completed
Date of protocol fixation
| 2016 | Year | 03 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
| 2016 | Year | 06 | Month | 01 | Day |
Date trial data considered complete
| 2016 | Year | 06 | Month | 01 | Day |
Date analysis concluded
Other
Other related information
attending anesthesiologists {Att} and anesthesia residents in our department participated in this simulation study. This study is approved by the institutional ethics committee of Yokohama City University school of Medicine Hospital. We set up a high-fidelity airway management simulator (MW11 Kyoto science) in the operating room. This simulator can measure the force onto the maxillary incisors and cervical spine extension angle in real time.
Management information
Registered date
| 2016 | Year | 04 | Month | 29 | Day |
Last modified on
| 2016 | Year | 10 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025514
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
