UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018944 |
|---|---|
| Receipt number | R000021918 |
| Scientific Title | Impact of AED device factors on defibrillation time and CPR quality: a randomized control trial. |
| Date of disclosure of the study information | 2015/09/09 |
| Last modified on | 2021/09/15 12:42:03 |
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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)
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
i_chida@meiji-u.ac.jp
Sponsor or person
Institute
Meiji University of Integrative Medicine
Institute
Department
Personal name
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)
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021918
