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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000021431
Receipt No. R000024721
Scientific Title The Effectiveness of high performance CPR for out-of-hospital cardiac arrests: a randomized control trial
Date of disclosure of the study information 2016/03/11
Last modified on 2020/07/27

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Basic information
Public title The Effectiveness of high performance CPR for out-of-hospital cardiac arrests: a randomized control trial
Acronym High performance CPR study
Scientific Title The Effectiveness of high performance CPR for out-of-hospital cardiac arrests: a randomized control trial
Scientific Title:Acronym High performance CPR study
Region
Japan

Condition
Condition Out-of-hospital cardiac arrests
Classification by specialty
Cardiology Anesthesiology Emergency medicine
Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the survival from out-of-hospital cardiac arrests between patients with or without high performance CPR by using CPR feedback devices.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1-month survival with favorable neurological outcome
Key secondary outcomes 1. Patient outcomes
1-month survival
Survival to hospital discharge
Return of spontaneous circulation
2. The data on CPR quality
Chest compression fraction
Chest compression depth
Chest compression rate
Ventilation volume / Ventilation rate

Base
Study type Interventional

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

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 To perform cardiopulmonary resuscitation with real-time feedback and debriefing by using CPR feedback device
Interventions/Control_2 To perform cardiopulmonary resuscitation without real-time feedback and debriefing by using CPR feedback device
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients 18 years old or older with medical cause related out-of-hospital cardiac arrest who received cardiopulmonary resuscitation by emergency medical services personnel
Key exclusion criteria 1. Pregnancy
2. Do-not attempt-resuscitation order
3. Refused to participate
Target sample size 3020

Research contact person
Name of lead principal investigator
1st name Taku
Middle name
Last name Iwami
Organization Kyoto University
Division name Health Services
Zip code 606-8501
Address Yoshida-honmachi, Sakyo-ku, Kyoto, Japan. 606-8501
TEL 075-753-2426
Email iwami.taku.8w@kyoto-u.ac.jp

Public contact
Name of contact person
1st name Norihiro
Middle name
Last name Nishioka
Organization Kyoto University
Division name Department of Preventive Services
Zip code 606-8501
Address Yoshida-honmachi, Sakyo-ku, Kyoto, Japan. 606-8501
TEL 075-753-2431
Homepage URL
Email nishioka.norihiro.26x@kyoto-u.jp

Sponsor
Institute Kyoto University
Institute
Department

Funding Source
Organization Grants-in-aid for Scientific Research-KAKENHI- Scientific Research (B)
ZOLL Medical Corporation
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 Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address Yoshida-Konoe-cho, Sakyo-ku, Kyoto 606-8501, JAPAN
Tel 075-753-4680
Email ethcom@kuhp.kyoto-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
2016 Year 03 Month 11 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 Open public recruiting
Date of protocol fixation
2016 Year 03 Month 03 Day
Date of IRB
Anticipated trial start date
2016 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 03 Month 11 Day
Last modified on
2020 Year 07 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024721

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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