UMIN-CTR Clinical Trial

Basic information
Public title	Video laryngoscope-assisted nasotracheal intubation by various supplemental technique
Acronym	Nasotracheal intubation using video laryngoscope
Scientific Title	Comparison of the effectiveness of nasotracheal intubation using a McGrath video laryngoscope with Magill forceps versus cuff-inflation technique.
Scientific Title:Acronym	Trial of nasotracheal intubation using a video laryngoscope with cuff-inflation technique.
Region	Japan

Condition
Condition	Oral and maxillofacial patient undergoing nasotracheal intubation
Classification by specialty	Anesthesiology Dental medicine Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The GlideScope video laryngoscope (GVL) is widely used for nasotracheal intubation in oral and maxillofacial surgery. The angle of the Magill forceps is different from that of the GVL blade, which suggests that the Magill forceps are not the ideal forceps for use with the GVL. The purpose of this study was to compare the effectiveness of the Magill forceps vs cuff inflation technique for nasotracheal intubation using the GVL.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Total intubation time, success rate
Key secondary outcomes

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	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	with Magill forceps
Interventions/Control_2	with cull-inflation technique
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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	adult patients undergoing oral and maxillofacial surgery under general anesthesia with nasotracheal intubation
Key exclusion criteria	facial deformity ASA PS III, IV
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Kanta Middle name Last name Kido
Organization	Kanagawa Dental University
Division name	Dept. of Anesthesiology
Zip code	238-8570
Address	1-23 Ogawa-cho, Yokosuka, Kanagawa, 238-8570, Japan
TEL	046-822-8810
Email	kido@kdu.ac.jp

Public contact
Name of contact person	1st name Kanta Middle name Last name Kido
Organization	Kanagawa Dental University
Division name	Dept, of Anesthesiology
Zip code	238-8570
Address	1-23 Ogawa-cho, Yokosuka, Kanagawa, 238-8570, Japan
TEL	046-822-8810
Homepage URL
Email	kido@kdu.ac.jp

Sponsor
Institute	International University of Health and Welfare
Institute
Department

Funding Source
Organization	Kanagawa Dental University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	International University of Health and Welfare
Address	537-3 Iguchi, Nasushiobara, Tochigi, 329-2763 Japan
Tel	0287-37-2221
Email	ejmasaki@gmail.com

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	国際医療福祉大学病院（栃木県）

Other administrative information
Date of disclosure of the study information	2019 Year 06 Month 01 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	Terminated
Date of protocol fixation	2019 Year 06 Month 01 Day
Date of IRB	2019 Year 06 Month 01 Day
Anticipated trial start date	2019 Year 06 Month 01 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 05 Month 13 Day
Last modified on	2019 Year 11 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000041844