UMIN-CTR Clinical Trial

Basic information
Public title	The efficacy of video laryngoscope on visualization of larynx in intubated patients
Acronym	The efficacy of video laryngoscope in intubated patients
Scientific Title	The efficacy of video laryngoscope on visualization of larynx in intubated patients
Scientific Title:Acronym	The efficacy of video laryngoscope in intubated patients
Region	Japan

Condition
Condition	Efficacy of video-laryngoscope on visualization of airway anatomy in tracheal intubated patients
Classification by specialty	Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Visualization of airway anatomy and manipulation facilitates tracheal tube exchange, nasogastric tube insertion and transesophageal echocardiography probe insertion. In intubated patients, classical Macintosh laryngoscope (Macintosh) is sometimes difficult to visualize airway anatomy. Video-laryngoscopes are known to provide better view of airway anatomy than Macintosh dose. However, efficacy of video-laryngoscope as an aid to visualize airway anatomy in intubated patients has not been evaluated. Thus, we evaluate the efficacy of two video-laryngoscopes; McGRATH MAC (McGRATH) and Airway Scope (AWS) as an aid for visualization of larynx in intubated patients compared with Macintosh.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Incidence of difficult airway anatomy visualization
Key secondary outcomes	Cormack-Lehane Grade

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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who underwent elective surgery and scheduled to admit ICU
Key exclusion criteria	Patients underwent neck surgery Patients with oropharyngeal infection or neck pain.
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Takashi Middle name Last name Ishida
Organization	Shinshu University of Medicine
Division name	Department of Anesthesiology and Resuscitology
Zip code	3908621
Address	3-1-1 Asahi, Matsumoto, Nagano, Japan
TEL	0263-37-2670
Email	tisd@shinshu-u.ac.jp

Public contact
Name of contact person	1st name Takashi Middle name Last name Ishida
Organization	Shinshu University of Medicine
Division name	Department of Anesthesiology and Resuscitology
Zip code	3908621
Address	3-1-1 Asahi, Matsumoto, Nagano, Japan
TEL	0263-37-2670
Homepage URL
Email	tisd@shinshu-u.ac.jp

Sponsor
Institute	Shinshu University of Medicine
Institute
Department

Funding Source
Organization	Shinshu University of Medicine Department of Anesthesiology and Resuscitology
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	Ethical committee of Shinshu University of Medicine
Address	3-1-1 Asahi, Matsumoto, Nagano, Japan
Tel	0263-37-2572
Email	mdrinri@shinshu-u.ac.jp

Secondary IDs
Secondary IDs	YES
Study ID_1	3677
Org. issuing International ID_1	Ethical committee of Shinshu University of Medicine
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2018 Year 05 Month 10 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled	20
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	Completed
Date of protocol fixation	2018 Year 05 Month 10 Day
Date of IRB	2017 Year 04 Month 04 Day
Anticipated trial start date	2018 Year 05 Month 10 Day
Last follow-up date	2019 Year 07 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	nothing

Management information
Registered date	2018 Year 05 Month 10 Day
Last modified on	2019 Year 11 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035025