UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011477 |
|---|---|
| Receipt number | 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 02:42:08 |
* 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
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
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
kusunoki@hiroshima-u.ac.jp
Sponsor or person
Institute
Department of Anesthesiology and Critical Care, Hiroshima University 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
Center for Integrated Medical Research, Hiroshima University Hospital
Address
1-2-3 Kasumi, Minami-ku, Hiroshima 734-8551, Japan
Tel
082-257-5596
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
Value
https://center6.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 |
