UMIN-CTR Clinical Trial

Basic information
Public title	Comparative trial of fully-automatic AED models
Acronym	Comparative trial of fully-automatic AED models
Scientific Title	Comparative trial of fully-automatic AED models
Scientific Title:Acronym	Comparative trial of fully-automatic AED models
Region	Japan

Condition
Condition	healthy adult
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Recently, three medical device manufacturers have developed and marketed different models of fully-automatic AEDs. However, there has been no comparison of the features of these models and the time it takes to administer an electric shock. The purpose of this study is to compare and clarify the features of each model in order to expand its use in the future.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Time from AED arrival to electroshock (seconds)
Key secondary outcomes	Time from AED arrival to power on (seconds), time from power on to pad application (seconds), time from pad application to electroshock (seconds), mental workload (NASA-TLX)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Placebo
Stratification	YES
Dynamic allocation
Institution consideration
Blocking	NO
Concealment

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Fully-automatic AED manufactured by NIHON KOHDEN
Interventions/Control_2	Fully-automatic AED manufactured by striker
Interventions/Control_3	Fully-automatic AED manufactured by Zoll
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	18 years-old <=
Age-upper limit	30 years-old >=
Gender	Male and Female
Key inclusion criteria	Kokushikan University students who are in good mental and physical health and can understand Japanese
Key exclusion criteria	Failure to obtain research consent, improper use of AEDs, missing data
Target sample size	150

Research contact person
Name of lead principal investigator	1st name Shuji Middle name Last name Sakanashi
Organization	Kokushikan University Graduate School
Division name	Department of Emergency Medical System
Zip code	206-8515
Address	7-3-1, Nagayama, Tama-City, Tokyo.
TEL	042-339-7200
Email	sakanashis@kokushikan.ac.jp

Public contact
Name of contact person	1st name shuji Middle name Last name Sakanashi
Organization	Kokushikan University Graduate School
Division name	Department of Emergency Medical System
Zip code	206-8515
Address	7-3-1, Nagayama, Tama-City, Tokyo.
TEL	042-339-7200
Homepage URL
Email	sakanashis@kokushikan.ac.jp

Sponsor
Institute	Kokushikan University
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kokushikan University
Address	7-3-1, Nagayama, Tama-City, Tokyo.
Tel	042-339-7200
Email	miurayu@kokushikan.ac.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	2022 Year 04 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished

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	Terminated
Date of protocol fixation	2022 Year 03 Month 31 Day
Date of IRB	2022 Year 03 Month 29 Day
Anticipated trial start date	2022 Year 04 Month 01 Day
Last follow-up date	2022 Year 06 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2022 Year 04 Month 01 Day
Last modified on	2022 Year 11 Month 22 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054010