UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000024387
Receipt No. 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 2018/03/19

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Middle name
Last name Taku Iwami
Organization Kyoto University
Division name Health Services
Zip code
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
Middle name
Last name Takafumi Kishimori
Organization Kyoto University
Division name Department of Preventive Services
Zip code
Address Yoshida-honmachi, Sakyo-ku, Kyoto, Japan. 606-8501
TEL 075-753-2431
Homepage URL
Email kishimorit@gmail.com

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 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
Address
Tel
Email

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
Anticipated trial start date
2016 Year 11 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 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
2018 Year 03 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028074

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.