UMIN-CTR Clinical Trial

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