UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036724 |
|---|---|
| Receipt number | 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 10:39:07 |
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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
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
kido@kdu.ac.jp
Sponsor or person
Institute
International University of Health and Welfare
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041844
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
