UMIN-CTR Clinical Trial

Basic information
Public title	Impact of AED device factors on defibrillation time and CPR quality: a randomized control trial.
Acronym	Impact of AED device factors on defibrillation time and CPR quality.
Scientific Title	Impact of AED device factors on defibrillation time and CPR quality: a randomized control trial.
Scientific Title:Acronym	Impact of AED device factors on defibrillation time and CPR quality.
Region	Japan

Condition
Condition	Cardiac arrest
Classification by specialty	Emergency medicine Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare the time to defibrillation and the quality of CPR according to 4 AED models.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Time from the AED arrival to shock delivery.
Key secondary outcomes	1.Time from AED has arrived the side of a patient to turn on the AED 2.Time from AED has arrived the side of a patient to place the defibrillator pads. 3.Time from shock delivery to star chest compression. 4.Positioning of defibrillator pad. 5.Number of chest compressions during two-minute period after the shock delivery. 6.Number of appropriate chest compressions during two-minute period after the shock delivery. 7.Number of chest compressions with appropriate depth during two-minute period after the shock delivery. 8.Time without chest compressions during two-minute period after the shock delivery.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	4
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Device,equipment
Interventions/Control_1	Heart Start FRx:PHILIPS
Interventions/Control_2	AED-2150:Nihonkohden
Interventions/Control_3	ZOLL AED Plus_integrated pad:Zoll
Interventions/Control_4	ZOLL AED Plus_Two pieces type pad:Zoll
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	Not applicable
Gender	Male and Female
Key inclusion criteria	People aged 18 years or more living in Japan and having skills on Japanese as their native language.
Key exclusion criteria	1.Healthcare professionals (medical doctor, nurse, pharmacist, nutritionist, medical technician, radiographer, occupational therapist, physical therapist, medical engineer, paramedic). And students majoring healthcare. 2.People who dedicate CPR training. 3.Those who have any physical disabilities.
Target sample size	110

Research contact person
Name of lead principal investigator	1st name Izumi Middle name Last name Chida
Organization	Meiji University of Integrative Medicine
Division name	School of Health Science and Medical Care Faculty of Emergency Medical Science
Zip code	629-0392
Address	Honoda,Hiyoshi-cho,Nantan-shi,Kyoto 629-0392 Japan
TEL	0771-72-1181(+81(0)771-72-1181)
Email	i_chida@meiji-u.ac.jp

Public contact
Name of contact person	1st name Izumi Middle name Last name Chida
Organization	Meiji University of Integrative Medicine
Division name	School of Health Science and Medical Care Faculty of Emergency Medical Science
Zip code	629-0392
Address	Honoda,Hiyoshi-cho,Nantan-shi,Kyoto 629-0392 Japan
TEL	0771-72-1181(+81(0)771-72-1181)
Homepage URL
Email	i_chida@meiji-u.ac.jp

Sponsor
Institute	Meiji University of Integrative Medicine
Institute
Department

Funding Source
Organization	Meiji University of Integrative Medicine
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Kyoto University
Name of secondary funder(s)	None

IRB Contact (For public release)
Organization	Meiji University of Integrative Medicine
Address	Honoda,Hiyoshi-cho,Nantan-shi,Kyoto 629-0392 Japan
Tel	0771-72-1181(+81(0)771-72-1181)
Email	sec_scie@meiji-u.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	2015 Year 09 Month 09 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	Completed
Date of protocol fixation	2015 Year 08 Month 20 Day
Date of IRB	2015 Year 08 Month 19 Day
Anticipated trial start date	2015 Year 08 Month 23 Day
Last follow-up date	2015 Year 09 Month 11 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2015 Year 09 Month 08 Day
Last modified on	2021 Year 09 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000021918