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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000023506
Receipt No. R000026994
Scientific Title The usefulness of the video laryngoscope for nasotracheal intubation
Date of disclosure of the study information 2016/08/05
Last modified on 2019/05/11

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Basic information
Public title The usefulness of the video laryngoscope for nasotracheal intubation
Acronym The usefulness of the video laryngoscope for nasotracheal intubation
Scientific Title The usefulness of the video laryngoscope for nasotracheal intubation
Scientific Title:Acronym The usefulness of the video laryngoscope for nasotracheal intubation
Region
Japan

Condition
Condition Healthy Adults
Classification by specialty
Anesthesiology Oral surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to examine the usefulness of
video laryngoscope for nasotracheal intubation
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1)Intubation time
2)Quality of view
3)Ease of blade insertion
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
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Interventions of this study is to use video laryngoscope
(Mac glass) for nasotracheal intubation.
Interventions/Control_2 Interventions of this study is to use video laryngoscope
(Airway scope) for nasotracheal intubation.
Interventions/Control_3 Interventions of this study is to use Macintosh
laryngoscope for nasotracheal intubation.
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
70 years-old >=
Gender Male and Female
Key inclusion criteria Healthy Adults
Key exclusion criteria The key exclusion criteria is as follows.
Patients who are expected to have a difficulty of tracheal
intubation before an intervention.
Target sample size 51

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Jun Harada
Organization Aichi Gakuin University
School of Dentistry
Division name Department of Anesthesiology
Zip code
Address 2-11 Suemori-dori, Chikusa-ku, Nagoya, Aichi, 464-8651, Japan
TEL 052-759-2111
Email hjun@dpc.agu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Aiji Boku
Organization Aichi Gakuin University School of Dentistry
Division name Department of Anesthesiology
Zip code
Address 2-11 Suemori-dori, Chikusa-ku, Nagoya, Aichi, 464-8651, Japan
TEL 052-759-2111
Homepage URL
Email bokuaiji@dpc.aichi-gakuin.ac.jp

Sponsor
Institute Aichigakuin University, School of Dentistry
Institute
Department

Funding Source
Organization Aichigakuin University, School of Dentistry
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
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 愛知学院大学歯学部附属病院(愛知県)

Other administrative information
Date of disclosure of the study information
2016 Year 08 Month 05 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
Tracheal intubation time was 27.0, 6.0 seconds (average, standard deviation) for the McG group, 38.0,12.0 seconds for the AWS group, and 36.0 , 10.0 seconds for the Macintosh group, indicating significantly shorter tracheal intubation time in the McG group than in the AWS group (p < 0.01) and the Macintosh group (p <0.05). Cormack Lehane grade was significantly improved in the M group compared to the N group (p< 0.05).
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 Main results already published
Date of protocol fixation
2016 Year 07 Month 15 Day
Date of IRB
2016 Year 07 Month 06 Day
Anticipated trial start date
2016 Year 08 Month 08 Day
Last follow-up date
2016 Year 12 Month 20 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 08 Month 05 Day
Last modified on
2019 Year 05 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026994

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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