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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017285
Receipt No. R000020056
Scientific Title Comparison of the usefulness of Air-Qsp and the i-gel for airway management
Date of disclosure of the study information 2015/04/28
Last modified on 2016/04/27

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Basic information
Public title Comparison of the usefulness of Air-Qsp and the i-gel for airway management
Acronym Comparison of the usefulness of Air-Qsp and the i-gel for airway management
Scientific Title Comparison of the usefulness of Air-Qsp and the i-gel for airway management
Scientific Title:Acronym 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

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

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
1st name
Middle name
Last name Mitsutaka Edanaga
Organization Sapporo Medical University School of Medicine
Division name Department of Anesthesiology
Zip code
Address S1, W16, Chuo-ku, Sapporo, Hokkaido, Japan
TEL 011-611-2111
Email edanaka@sapmed.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazuhiro Nakane
Organization Sapporo Medical University School of Medicine
Division name Hospital Division
Zip code
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

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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Partially published

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 Completed
Date of protocol fixation
2013 Year 01 Month 07 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000020056

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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