UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000033370
Receipt No. 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 (Ver. 4)

* 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 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
Email 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
Email ajimi@is.icc.u-tokai.ac.jp

Sponsor
Institute Department of Anesthesiology, Hachioji-Hospital, Tokai University of School of Medicine
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000038041