UMIN-CTR Clinical Trial

Basic information
Public title	Efficacy of proximal bending of an intubating stylet at indirect tracheal intubation using a McGRATH videolaryngoscope.
Acronym	Efficacy of proximal bending of an intubating stylet at indirect tracheal intubation using a McGRATH videolaryngoscope.
Scientific Title	Efficacy of proximal bending of an intubating stylet at indirect tracheal intubation using a McGRATH videolaryngoscope.
Scientific Title:Acronym	Efficacy of proximal bending of an intubating stylet at indirect tracheal intubation using a McGRATH videolaryngoscope.
Region	Japan

Condition
Condition	Tracheal intubation
Classification by specialty	Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to investigate that using the stylet with the proximal bended 45 degrees forward facilitates intubation compared to using the stylet with the proximal bended 45 degrees to the right under using a McGRATH videolaryngoscope.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase

Assessment
Primary outcomes	Time for endotracheal tube induction
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Dose comparison
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Pseudo-randomization

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment Maneuver
Interventions/Control_1	Stylet with distal bended 60 degrees forward and the proximal bended 45 degrees forward.
Interventions/Control_2	Stylet with distal bended 60 degrees forward and the proximal bended 45 degrees to the right.
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	Patients undergoing general anesthesia by tracheal intubation
Key exclusion criteria	Ptients with anticipated ventilator or intubation difficulties Patients with serious cerebrovascular disease, ischemic heart disease, or respiratory failure Isolated pulmonary ventilation case Awake intubation by bronchoscope Naso-tracheal intubation Tracheostomy patient
Target sample size	90

Research contact person
Name of lead principal investigator	1st name Ringa Middle name Last name You
Organization	JCHO Chukyo Hospital
Division name	Department of Anesthesiology
Zip code	457-8510
Address	1-1-10, Sanjou, Minami, Nagoya, Aichi
TEL	052-691-7151
Email	tai_1_lan@icloud.com

Public contact
Name of contact person	1st name Ringa Middle name Last name You
Organization	JCHO Chukyo Hospital
Division name	Department of Anesthesiology
Zip code	457-8510
Address	1-1-10, Sanjou, Minami, Nagoya, Aichi
TEL	052-691-7151
Homepage URL
Email	tai_1_lan@icloud.com

Sponsor
Institute	JCHO Chukyo Hospital Department of Anesthesiology
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	None
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Ethical review board of JCHO Chukyo hospital
Address	1-1-10, Sanjou, Minami, Nagoya, Aichi
Tel	052-691-7151
Email	tai_1_lan@icloud.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	JCHO中京病院

Other administrative information
Date of disclosure of the study information	2022 Year 08 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	Preinitiation
Date of protocol fixation	2022 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date	2022 Year 08 Month 01 Day
Last follow-up date	2022 Year 10 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2023 Year 06 Month 30 Day

Other
Other related information

Management information
Registered date	2022 Year 07 Month 26 Day
Last modified on	2022 Year 07 Month 27 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055241

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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