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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018013
Receipt No. R000020877
Scientific Title Comparison of the usefulness of Airway Scope for nasotracheal intubation with that of McGRATH-MAC under oral surgery
Date of disclosure of the study information 2015/06/23
Last modified on 2018/06/24

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Basic information
Public title Comparison of the usefulness of Airway Scope for nasotracheal intubation with that of McGRATH-MAC under oral surgery
Acronym Comparison of the usefulness of Airway Scope for nasotracheal intubation with that of McGRATH-MAC under oral surgery
Scientific Title Comparison of the usefulness of Airway Scope for nasotracheal intubation with that of McGRATH-MAC under oral surgery
Scientific Title:Acronym Comparison of the usefulness of Airway Scope for nasotracheal intubation with that of McGRATH-MAC under oral surgery
Region
Japan

Condition
Condition the patients performed nasotracheal intubation for oral surgery
Classification by specialty
Anesthesiology Oral surgery Plastic surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 to examine adequate device for nasotracheal intubation
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes the number of success of nasotracheal intubation, the time of success of nasotracheal intubation and the time to confirm the vocal cord.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Airwayscope was used during general anesthesia induction. Clinical study will be two days.
Interventions/Control_2 McGRATH-MAC was used during general anesthesia induction. Clinical study will be two days.
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
80 years-old >=
Gender Male and Female
Key inclusion criteria the patients proposed to performe nasotracheal intubation for oral surgery
Key exclusion criteria the patients whom are unconsciousness and not be agreed to participate our study
Target sample size 140

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mitsutaka Edanaga
Organization Sapporo Medical University School of Medicine
Division name Department of Anesthesiology
Zip code
Address S1, W16, Chuo-ku, Sapporo, Hokkaido
TEL 011-611-2111
Email edanaka@sapmed.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Aki Fujito
Organization Sapporo Medical University School of Medicine
Division name Hospital Division
Zip code
Address S1, W16, Chuo-ku, Sapporo, Hokkaido
TEL 011-611-2111
Homepage URL
Email akifujito@sapmed.ac.jp

Sponsor
Institute Sapporo Medical University School of Medicine
Institute
Department

Funding Source
Organization Department of Anesthesiology, Sapporo Medical University School of Medicine
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
Address
Tel
Email

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
2015 Year 06 Month 23 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
2015 Year 05 Month 20 Day
Date of IRB
Anticipated trial start date
2015 Year 07 Month 06 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 06 Month 22 Day
Last modified on
2018 Year 06 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020877

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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