UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041457 |
|---|---|
| Receipt number | R000047324 |
| Scientific Title | Improvement of glottic view by back-up position during tracheal intubation using video laryngoscopy |
| Date of disclosure of the study information | 2020/08/18 |
| Last modified on | 2020/08/18 16:29:56 |
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Basic information
Public title
Improvement of glottic view by back-up position during tracheal intubation using video laryngoscopy
Acronym
Improvement of glottic view by back-up position during tracheal intubation using video laryngoscopy
Scientific Title
Improvement of glottic view by back-up position during tracheal intubation using video laryngoscopy
Scientific Title:Acronym
Improvement of glottic view by back-up position during tracheal intubation using video laryngoscopy
Region
| Asia(except Japan) |
Condition
Condition
clinical trial: observational study
Classification by specialty
| Medicine in general | Anesthesiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We would like to see if taking the back-up position when tracheal intubation using video laryngoscope can improve visibility and increase the success rate of intubation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The change in percentage of glottic opening (POGO score): primary outome
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 19 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
An adult patient undergoing general anesthesia (ASA 1 or 2) who has undergone surgery under general anesthesia, followed by a video laryngeal examination with Cormack-Lehane grade 3 or 4 patients.
Key exclusion criteria
ASA class above 3
Patients who refuse to participate in the study or who cannot receive informed comments
Patient with Cormack-Lehane grade 1 or 2 in video laryngoscopy
Patients who have difficulty ventilating water after losing consciousness
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | Bon Wook |
| Middle name | |
| Last name | Koo |
Organization
Seoul National University Bundang Hospital
Division name
Department of Anesthesiology and Pain Medicine
Zip code
13620
Address
82 Gumi-ro, 173 Beon-gil Bundang-gu, Seongnam Gyeonggi-do, Republic of Korea
TEL
031-787-7499
tendong2@gmail.com
Public contact
Name of contact person
| 1st name | Bo Young |
| Middle name | |
| Last name | Kim |
Organization
Seoul National University Bundang Hospital
Division name
Department of Anesthesiology and Pain Medicine
Zip code
13620
Address
82 Gumi-ro, 173 Beon-gil Bundang-gu, Seongnam Gyeonggi-do, Republic of Korea
TEL
031-787-7499
Homepage URL
to123215@gmail.com
Sponsor or person
Institute
Seoul National University Bundang Hospital
Institute
Department
Personal name
Funding Source
Organization
Seoul National University Bundang Hospital
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
Seoul National University Bundang Hospital, IRB
Address
82 Gumi-ro, 173 Beon-gil Bundang-gu, Seongnam Gyeonggi-do, Republic of Korea
Tel
82-31-787-3941
ctc01@snubh.org
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
| 2020 | Year | 08 | Month | 18 | 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
Open public recruiting
Date of protocol fixation
| 2019 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 12 | Day |
Anticipated trial start date
| 2020 | Year | 08 | Month | 18 | Day |
Last follow-up date
| 2020 | Year | 08 | Month | 18 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Select Cormack-Lehane grade 3 or 4 patients from the video laryngeal examination after inducing general anesthesia among adult patients who agreed to participate in this study under general anesthesia.
In case of Cormack-Lehane grade 3 or 4 patients, the researchers perform a back-up position using the remote control of the surgical bed. Adjust the degree of back-up to find the best POGO score. Compare the POGO score before and after position change.
Management information
Registered date
| 2020 | Year | 08 | Month | 18 | Day |
Last modified on
| 2020 | Year | 08 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047324
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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