UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021431 |
|---|---|
| Receipt number | R000024721 |
| Scientific Title | Real-time Feedback, Debriefing, and Retraining for System-Level High-Quality CPR |
| Date of disclosure of the study information | 2016/03/11 |
| Last modified on | 2026/03/23 18:04:04 |
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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
Real-time Feedback, Debriefing, and Retraining for System-Level High-Quality CPR
Scientific Title:Acronym
REFRESH-OHCA Trial
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
Favorable neurological survival at 1 month or at hospital discharge, whichever occurred first, assessed using the Cerebral Performance Category (CPC) scale
Key secondary outcomes
1. Patient outcomes
Survival(1 month or at hospital discharge, whichever occurred first)
Prehospital return of spontaneous circulation
2. The data on CPR quality
Chest compression fraction
Chest compression depth
Chest compression rate
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
Department of Preventive Services, Graduate School of Medicine
Zip code
606-8501
Address
Yoshida-konoe, Sakyo-ku, Kyoto, Japan. 606-8501
TEL
075-753-4400
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-konoe, Sakyo-ku, Kyoto, Japan. 606-8501
TEL
075-753-4400
Homepage URL
nishioka.norihiro.26x@kyoto-u.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Grants-in-aid for Scientific Research-KAKENHI- Scientific Research (B)
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
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
No longer recruiting
Date of protocol fixation
| 2016 | Year | 03 | Month | 03 | Day |
Date of IRB
| 2016 | Year | 04 | Month | 07 | Day |
Anticipated trial start date
| 2016 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2024 | 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
| 2016 | Year | 03 | Month | 11 | Day |
Last modified on
| 2026 | Year | 03 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024721
