UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Comparison of the usefulness of AirwayScope with McGRATH and GlideScope during tracheal intubation in pediatrics
Title of the study (Brief title)	Comparison of the usefulness of AirwayScope with McGRATH and GlideScope during tracheal intubation in pediatrics
Region	Japan

Condition
Condition	Pediatric patients whom were scheduled to operation
Classification by specialty	Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose is to decide the usefulness of tracheal intubation for pediatrics among the three tracheal device
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	successful rate of intubation, the time to tracheal intubation, comparison of blood pressure, heart rate and saturation at post-intubation with that of pre-intubation
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	airway scope will be used during endotracheal intubation. Intervention will be continued for 2 days.
Interventions/Control_2	McGRATH will be used during endotracheal intubation. Intervention will be continued for 2 days.
Interventions/Control_3	Glidescope will be used during endotracheal intubation. Intervention will be continued for 2 days.
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	1 years-old <=
Age-upper limit	5 years-old >=
Gender	Male and Female
Key inclusion criteria	pediatrics whom were scheduled to operation
Key exclusion criteria	pediatrics were complicated with athma and upper respiratory tract infection when parents of patients refused the participation of the study
Target sample size	60

Research contact person
Name of lead principal investigator	Mitsutaka Edanaga
Organization	Sapporo Medical University School of Medicine
Division name	Department of Anesthesiology
Address	S1, W16, Chuo-ku, Sapporo, Hokkaido, Japan
TEL	011-611-2111
Email	edanaka@sapmed.ac.jp

Public contact
Name of contact person	Kazuhiro Nakane
Organization	Sapporo Medical University School of Medicine
Division name	Department of Anesthesiology
Address	S1, W16, Chuo-ku, Sapporo, Hokkaido, Japan
TEL	011-611-2111
Homepage URL
Email	akifujito@sapmed.ac.jp

Sponsor
Institute	Sapporo Medical University School of Medicine
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Department of Anesthesiology, Sapporo Medical University School of Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2015 Year 05 Month 02 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2014 Year 06 Month 20 Day
Anticipated trial start date	2015 Year 12 Month 07 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 05 Month 01 Day
Last modified on	2016 Year 05 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020164