UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005715 |
|---|---|
| Receipt number | R000006756 |
| Scientific Title | Efficacy of Coopdech videolaryngoscope : Comparisons with a Macintosh laryngoscope and the Airway Scope in a manikin with difficult airways |
| Date of disclosure of the study information | 2011/06/03 |
| Last modified on | 2011/06/03 16:33:01 |
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Basic information
Public title
Efficacy of Coopdech videolaryngoscope : Comparisons with a Macintosh laryngoscope and the
Airway Scope in a manikin with difficult airways
Acronym
Efficacy of Coopdech videolaryngoscope : Comparisons with a Macintosh laryngoscope and the
Airway Scope in a manikin with difficult airways
Scientific Title
Efficacy of Coopdech videolaryngoscope : Comparisons with a Macintosh laryngoscope and the
Airway Scope in a manikin with difficult airways
Scientific Title:Acronym
Efficacy of Coopdech videolaryngoscope : Comparisons with a Macintosh laryngoscope and the
Airway Scope in a manikin with difficult airways
Region
| Japan |
Condition
Condition
a manikin with difficult airways
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The main aim of the study was to assess the efficacy of the Coopdech Videolaryngoscope Portable by comparing it with the Macintosh laryngoscope and with an established videolaryngoscope, the Airway Scope in simulated difficult airways.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The main aim of the study was to compare the success rate of tracheal intubation (within 120 s) between the three laryngoscopes.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
5
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
manikin with normal airway.
the view of the glottis at laryngoscopy was graded.The time to see the glottis, the time to intubate the trachea and the success rate of tracheal intubation were recorded.
Interventions/Control_2
manikin with tongue oedema.
the view of the glottis at laryngoscopy was graded.The time to see the glottis, the time to intubate the trachea and the success rate of tracheal intubation were recorded.
Interventions/Control_3
manikin with cervical spine rigidity.
the view of the glottis at laryngoscopy was graded.The time to see the glottis, the time to intubate the trachea and the success rate of tracheal intubation were recorded.
Interventions/Control_4
manikin with pharyngeal obstruction.
the view of the glottis at laryngoscopy was graded.The time to see the glottis, the time to intubate the trachea and the success rate of tracheal intubation were recorded.
Interventions/Control_5
manikin with laryngospasm.
the view of the glottis at laryngoscopy was graded.The time to see the glottis, the time to intubate the trachea and the success rate of tracheal intubation were recorded.
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Fifty medical residents, who were rotating to our department of Anaesthetics, participated to this study. All participants had performed less than 10 tracheal intubations within the initial 1 mo of training.
Key exclusion criteria
medical residents, who were not rotating to our department of Anaesthetics
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomoyuki Saito |
Organization
Dokkyo Medical University Koshigaya Hospital
Division name
Department of Anaesthesiology
Zip code
Address
2-1-50 Minamikoshigaya, Koshigaya City, Saitama, 343-8555, Japan.
TEL
048-965-1111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomoyuki Saito |
Organization
Dokkyo Medical University Koshigaya Hospital
Division name
Department of Anaesthesiology
Zip code
Address
2-1-50 Minamikoshigaya, Koshigaya City, Saitama, 343-8555, Japan
TEL
048-965-1111
Homepage URL
s-tomo@dokkyomed.ac.jp
Sponsor or person
Institute
Dokkyo Medical University Koshigaya Hospital
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
| 2011 | 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
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
| 2008 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 01 | 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
| 2011 | Year | 06 | Month | 03 | Day |
Last modified on
| 2011 | Year | 06 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006756
