UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Comparison of the usefulness of Air-Qsp and the i-gel for airway management
Title of the study (Brief title)	Comparison of the usefulness of Air-Qsp and the i-gel for airway management
Region	Japan

Condition
Condition	patients whom scheduled to operation under general anesthesia
Classification by specialty	Vascular surgery Breast surgery Ophthalmology Dermatology Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study was to compare the usefulness of Air-Qsp with that of i-gel for airway management in Japanese adult patients.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The number of insertions, duration of insertion, change of systolic blood pressure during insertion, delivered tidal volume for setting volume control ventilation
Key secondary outcomes	the distribution of fiber tips through ILAs and plotted the center of the view using clock face diagram

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	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Air-Qsp was used during operation
Interventions/Control_2	i-gel group was used during operation
Interventions/Control_3
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	20 years-old <=
Age-upper limit	70 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients aged 20-70 years, with ASA physical status I or II, and scheduled for elective surgery under general anesthesia in the supine position
Key exclusion criteria	Patients whom are unconscious and refused participation of the study
Target sample size	100

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	Hospital Division
Address	S1, W16, Chuo-ku, Sapporo, Hokkaido, Japan
TEL	011-611-2111
Homepage URL
Email	akifujito@sapmed.ac.jp

Sponsor
Institute	Department of Anesthesiology, 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	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 04 Month 28 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 01 Month 07 Day
Anticipated trial start date	2013 Year 04 Month 01 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	Partially published
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 04 Month 27 Day
Last modified on	2016 Year 04 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000020056