UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000017285
Receipt number 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 21:18:04

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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 or person

Institute

Department of Anesthesiology, Sapporo Medical University School of Medicine

Institute

Department

Personal name



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

Value
https://center6.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