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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000036724
Receipt No. R000041844
Scientific Title Comparison of the effectiveness of nasotracheal intubation using a McGrath video laryngoscope with Magill forceps versus cuff-inflation technique.
Date of disclosure of the study information 2019/06/01
Last modified on 2019/11/12

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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/ctr_e/ctr_view.cgi?recptno=R000041844

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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