UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024387 |
|---|---|
| Receipt number | R000028074 |
| Scientific Title | The impact of the quality of cardiopulmonary resuscitation by EMS personnel for outcomes from out-of-hospital cardiac arrests |
| Date of disclosure of the study information | 2016/10/13 |
| Last modified on | 2023/09/16 10:01:16 |
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Basic information
Public title
The impact of the quality of cardiopulmonary resuscitation by EMS personnel for outcomes from out-of-hospital cardiac arrests
Acronym
The cohort study on the quality of cardiopulmonary resuscitation
Scientific Title
The impact of the quality of cardiopulmonary resuscitation by EMS personnel for outcomes from out-of-hospital cardiac arrests
Scientific Title:Acronym
The cohort study on the quality of cardiopulmonary resuscitation
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 evaluate the association between outcomes from out-of-hospital cardiac arrests and the quality of cardiopulmonary resuscitation
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1-month survival with favorable neurological outcomes; cerebral performance category 1 or 2 as favorable neurological outcomes
Key secondary outcomes
1.Chest compression fraction
2. Return of spontaneous circulation
3.Survival to admission
4.1-month survival
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 8 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
All patients 8 years old or older with out-of-hospital cardiac arrest who received cardiopulmonary resuscitation by emergency medical services personnel with defibrillators, which can record the quality of cardiopulmonary resuscitation
Key exclusion criteria
Not applicable
Target sample size
3850
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
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
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)
ZOLL Medical Corporation
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan, The United States of America
Other related organizations
Co-sponsor
ZOLL Medical Corporation
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 | 10 | Month | 13 | 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 | 10 | Month | 17 | Day |
Date of IRB
| 2016 | Year | 04 | Month | 07 | Day |
Anticipated trial start date
| 2016 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1. Study design
Prospective cohort study
2. Study setting
Japanese fire departments which can use defibrillators, which can record the quality of cardiopulmonary resuscitation, during the study period
3. Registry procedures of fire departments
Researchers give the presentation on this study to each Japanese fire department. After finishing the presentation, researchers collect agreements from participative fire departments
4. Collected data
1.Patients characteristics
Sex, Age, Activities of daily life before arrests, Witnessed status, Relation of the bystander to the patient, Locations of arrests, Situation of arrests, Dispatcher cardiopulmonary resuscitation, Automated external defibrillator use by a general public, Bystander cardiopulmonary resuscitation, Initial electrocardiogram rhythm, Advanced cardiac life support, Scene time interval, Cause of cardiac arrest, Return of spontaneous circulation, 1-month survival, 1-month survival or discharge with cerebral performance category, Physician presences on ambulance car or ambulance helicopter
2.Emergency medical services personnel characteristics
Years of experience as emergency medical services personnel, License on emergency lifesaving technician
3.The data on defibrillators, which can record the quality of cardiopulmonary resuscitation
The type of defibrillators, Real-time feedback on the scene by using the data on the quality of cardiopulmonary resuscitation, Debriefing after events by using the data on the quality of cardiopulmonary resuscitation
4.The data on CPR quality
Chest compression fraction
Chest compression depth
Chest compression rate
Ventilation volume and ventilation rate
Management information
Registered date
| 2016 | Year | 10 | Month | 13 | Day |
Last modified on
| 2023 | Year | 09 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028074
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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