UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of the maximum force onto the maxillary incisors and cervical spine motion during endotracheal intubation using simulator. Comparison by anesthetic experience or by types of laryngoscope.
Title of the study (Brief title)	Evaluation of the maximum force onto the maxillary incisors and cervical spine motion during endotracheal intubation using simulator.
Region	Japan

Condition
Condition	tracheal intubation
Classification by specialty	Anesthesiology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is measuring the force onto the maxillary incisors and the cervical spine motion and comparison by anesthetic experience or by types of laryngoscope in simulation settings.
Basic objectives2	Others
Basic objectives -Others	The aim of this study is measuring the force onto the maxillary incisors and the cervical spine motion and comparison by anesthetic experience or by types of laryngoscope in simulation settings.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	force onto the maxillary incisors during endotracheal intubation
Key secondary outcomes	cervical spine motion during endotracheal intubation

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
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	20 years-old <=
Age-upper limit	65 years-old >=
Gender	Male and Female
Key inclusion criteria	anesthesiologists who can intubate with direct laryngoscope and video laryngoscope
Key exclusion criteria	in case of esophageal intubation
Target sample size	40

Research contact person
Name of lead principal investigator	Hitoshi Sato
Organization	Yokohama City University Graduate School of Medical Sciences and School of Medicine
Division name	Department of Anesthesiology
Address	3-9 Fuku-ura, Kanazawa-ku, Yokohama 236-0004, JAPAN
TEL	045-787-2918
Email	sjinkun@yokohama-cu.ac.jp

Public contact
Name of contact person	Hitoshi Sato
Organization	Yokohama City University Graduate School of Medical Sciences and School of Medicine
Division name	Department of Anesthesiology
Address	3-9 Fuku-ura, Kanazawa-ku, Yokohama 236-0004, JAPAN
TEL	045-787-2918
Homepage URL
Email	sjinkun@yokohama-cu.ac.jp

Sponsor
Institute	Yokohama City University Graduate School of Medical Sciences and School of Medicine
Institute
Department

Funding Source
Organization	Yokohama City University Graduate School of Medical Sciences and School of Medicine
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2016 Year 05 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 03 Month 15 Day
Anticipated trial start date	2016 Year 05 Month 01 Day
Last follow-up date	2016 Year 06 Month 01 Day
Date of closure to data entry	2016 Year 06 Month 01 Day
Date trial data considered complete	2016 Year 06 Month 01 Day
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	attending anesthesiologists {Att} and anesthesia residents in our department participated in this simulation study. This study is approved by the institutional ethics committee of Yokohama City University school of Medicine Hospital. We set up a high-fidelity airway management simulator (MW11 Kyoto science) in the operating room. This simulator can measure the force onto the maxillary incisors and cervical spine extension angle in real time.

Management information
Registered date	2016 Year 04 Month 29 Day
Last modified on	2016 Year 10 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025514