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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005715
Receipt No. 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

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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
Email

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
Email s-tomo@dokkyomed.ac.jp

Sponsor
Institute Dokkyo Medical University Koshigaya Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006756

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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