UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033370 |
|---|---|
| Receipt number | R000038041 |
| Scientific Title | Usefulness of Airtraq sumaho adapterTM in a manikin study |
| Date of disclosure of the study information | 2018/07/30 |
| Last modified on | 2020/05/11 10:38:13 |
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Basic information
Public title
Usefulness of Airtraq sumaho adapterTM
in a manikin study
Acronym
Usefulness of Airtraq sumaho adapterTM
in a manikin study
Scientific Title
Usefulness of Airtraq sumaho adapterTM
in a manikin study
Scientific Title:Acronym
Usefulness of Airtraq sumaho adapterTM
in a manikin study
Region
| Japan |
Condition
Condition
in a manikin study
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The Airtrack DLTM is a video laryngoscope dedicated to DLT. Since you have to look in the eye cup when using it, there was a problem in operability. This time, The Airtraq sumaho adapterTM (device capable of recording moving pictures during intubation using monitor display and recording function of smartphone etc.) connected to the eye cup is on the market. We want to evaluate its operability and usefulness.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Intubation time
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Maneuver |
Interventions/Control_1
Comparison of the double lumen tube intubation time between the Airtrack DLTM and the Airtrack DLTM with the Aortraq sumaho adapterTM
Interventions/Control_2
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
| 30 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Anesthesiologists with clinical experience over 5 years
Key exclusion criteria
Without concent
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Ritsuko |
| Middle name | |
| Last name | Masuda |
Organization
Hachioji-Hospital, Tokai University of School of Medicine
Division name
Department of Anesthesiology
Zip code
1920032
Address
1838 Ishikiawamachi, Hachioji, Tokyo, Japan
TEL
042-639-1111
ajimi@is.icc.u-tokai.ac.jp
Public contact
Name of contact person
| 1st name | Junko |
| Middle name | |
| Last name | Ajimi |
Organization
Hachioji-Hospital, Tokai University of School of Medicine
Division name
Department of Anesthesiology
Zip code
1920032
Address
1838 Ishikiawamachi, Hachioji, Tokyo, Japan
TEL
042-639-1111
Homepage URL
ajimi@is.icc.u-tokai.ac.jp
Sponsor or person
Institute
Department of Anesthesiology, Hachioji-Hospital, Tokai University of School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Anesthesiology, Hachioji-Hospital, Tokai University of 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
Clinical Research Administration Office ,Tokai UniversityHospital
Address
143 Shimokasuya, Isehara, Kanagawa
Tel
0463-93-1121
tokai-rinsho@ml.tokai-u.jp
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
| 2018 | Year | 07 | Month | 30 | Day |
Related information
URL releasing protocol
Tokai J Exp Clin Med., Vol. 43, No. 4, pp. 139-142, 2018
Publication of results
Published
Result
URL related to results and publications
Tokai J Exp Clin Med., Vol. 43, No. 4, pp. 139-142, 2018
Number of participants that the trial has enrolled
13
Results
The mean time required for intubation was shorter in the adapter phase than in the Airtraq-alone phase for all anesthesiologists.
Results date posted
| 2020 | Year | 05 | Month | 11 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
anesthesiologists with more than 5 years clinical experience
Participant flow
The anesthesiologists used two types of devices, Airtraq DL TM alone and the Airtraq DL TM attached to the Universal Adapter for Smartphones TM, to insert the 35-Fr Shiley TM endobronchial tube with left polyurethane cuff into Airism TM, a tracheal intubation training mannequin.
Adverse events
none
Outcome measures
The time required for intubation
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 03 | Month | 27 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 27 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 07 | Month | 12 | Day |
Last modified on
| 2020 | Year | 05 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038041
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
