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 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
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
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
