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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011477
Receipt No. R000013434
Scientific Title A clinical trial to investigate the efficacy and safety of video-laryngoscopes for education of tracheal intubation
Date of disclosure of the study information 2013/08/13
Last modified on 2019/08/09

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Basic information
Public title A clinical trial to investigate the efficacy and safety of video-laryngoscopes for education of tracheal intubation
Acronym Comparison of video-laryngoscopes and conventional Macintosh laryngoscope to facilitate tracheal intubation by inexperienced personnel
Scientific Title A clinical trial to investigate the efficacy and safety of video-laryngoscopes for education of tracheal intubation
Scientific Title:Acronym Comparison of video-laryngoscopes and conventional Macintosh laryngoscope to facilitate tracheal intubation by inexperienced personnel
Region
Japan

Condition
Condition Patients undergoing elective surgery with general anesthesia
Classification by specialty
Anesthesiology Emergency medicine Intensive care medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Tracheal intubation with a conventional direct laryngoscope is a difficult skill to acquire and proficiency deteriorates over time without regular practice. However, personnel with insufficient skills may be required to perform tracheal intubation in emergency situations. The Airtraq and PENTAX-AWS are indirect laryngoscopes developed to facilitate tracheal intubation under various conditions, including emergency settings. These devices have similar types of blades, which are shaped to fit the oropharyngeal anatomy and enable even less experienced operators to achieve an optimal view of the glottis. In the present study, we will compare these indirect laryngoscopes along with a conventional Macintosh laryngoscope during intubation performed by inexperienced medical personnel in regard to success rate, time and number of attempts required, and difficulty.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes We assesse success rate, intubation time, and number of attempts of each device.
At the end of the study period, each resident score the difficulty of the intubation attempts for each device.
Key secondary outcomes We assesse complications from the use of each device.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Prior to the study, all residents receive the same pre-clinical training course including manikin practice.
Interventions/Control_2 The participants are asked to intubate the patients using an Airtraq, PENTAX-AWS, or Macintosh laryngoscope in the operating room.
Interventions/Control_3 Each participant intubates 5 patients with each device in random order under close supervision of attending anesthesiologists. An intubation procedure not completed after two 60-second attempts is defined as failure.
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 Patients who are elder over 18 yr have to undergo elective surgery under general anesthesia requiring tracheal intubation, and have to be classified as American Society of Anesthesiologists physical status I-III.
Key exclusion criteria Patients are excluded from the trial if they have a known or predicted difficult airway, oropharyngeal pathology, cervical spine disease, a body mass index >30 kg/m2, or are at increased risk of regurgitation of gastric contents, or where there is a history of relevant drug allergy.
Target sample size 500

Research contact person
Name of lead principal investigator
1st name Shinji
Middle name
Last name Kusunoki
Organization Hiroshima University Hospital
Division name Department of Anesthesiology and Critical Care
Zip code 734-8551
Address 1-2-3 Kasumi, Minami-ku, Hiroshima 734-8551, Japan
TEL 082-257-5267
Email kusunoki@hiroshima-u.ac.jp

Public contact
Name of contact person
1st name Shinji
Middle name
Last name Kusunoki
Organization Hiroshima University Hospital
Division name Department of Anesthesiology and Critical Care
Zip code 34-8551
Address 1-2-3 Kasumi, Minami-ku, Hiroshima 734-8551, Japan
TEL 082-257-5267
Homepage URL
Email kusunoki@hiroshima-u.ac.jp

Sponsor
Institute Department of Anesthesiology and Critical Care, Hiroshima University 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 Center for Integrated Medical Research, Hiroshima University Hospital
Address 1-2-3 Kasumi, Minami-ku, Hiroshima 734-8551, Japan
Tel 082-257-5596
Email hugcp@hiroshima-u.ac.jp

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 広島大学病院(広島県)

Other administrative information
Date of disclosure of the study information
2013 Year 08 Month 13 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
2007 Year 08 Month 01 Day
Date of IRB
2004 Year 03 Month 05 Day
Anticipated trial start date
2007 Year 08 Month 01 Day
Last follow-up date
2015 Year 09 Month 13 Day
Date of closure to data entry
2015 Year 09 Month 13 Day
Date trial data considered complete
2015 Year 09 Month 13 Day
Date analysis concluded
2015 Year 09 Month 13 Day

Other
Other related information

Management information
Registered date
2013 Year 08 Month 13 Day
Last modified on
2019 Year 08 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013434

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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