UMIN-CTR Clinical Trial

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
Email	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
Email	to123215@gmail.com

Sponsor
Institute	Seoul National University Bundang Hospital
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047324