UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000002061
Receipt number R000002514
Scientific Title Effectiveness of mass training program of simplified chest compression-only CPR for the general public: Community intervention trial based on a large cohort
Date of disclosure of the study information 2009/06/30
Last modified on 2009/06/10 14:24:25

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Basic information

Public title

Effectiveness of mass training program of simplified chest compression-only CPR for the general public: Community intervention trial based on a large cohort

Acronym

Effectiveness of simplified chest compression-only CPR: Community intervention trial

Scientific Title

Effectiveness of mass training program of simplified chest compression-only CPR for the general public: Community intervention trial based on a large cohort

Scientific Title:Acronym

Effectiveness of simplified chest compression-only CPR: Community intervention trial

Region

Japan


Condition

Condition

Cardiac arrest

Classification by specialty

Emergency medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate whether the spread of a mass training program of compression-only CPR can increase the proportion of bystander CPR and survival from out-of-hospital cardiac arrests.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

Proportion of bystander CPR

Key secondary outcomes

1. Type of bystander CPR
2. VF as the initially recorded rhythm
3. AED use by the general public
4. Resuscitation time course
5. 1-month survival
6. Neurologically intact survival from witnessed OHCA of presumed cardiac etiology


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Maneuver

Interventions/Control_1

The chest compression-only CPR group members were provided with a 45-minute mass training program consisting of continuous chest compressions and an AED operation.

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

11 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Citizens aged 11 years or more who live or work in the study area.

Key exclusion criteria

Those who have physical disabilities to perform CPR or are considered to be unsuitable for CPR training.

Target sample size

56000


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Taku Iwam

Organization

Kyoto University

Division name

Health Service

Zip code


Address

Yoshida-Honmachi, Sakyo-ku, Kyoto, 606-8501

TEL

075-753-2401

Email



Public contact

Name of contact person

1st name
Middle name
Last name Chika Nishiyama

Organization

Kyoto University

Division name

Department of Preventive Services, Kyoto University School of Public Health

Zip code


Address

Yoshida-Honmachi, Sakyo-ku, Kyoto, 606-8501

TEL

075-753-2431

Homepage URL


Email

c-nishi@st.pbh.med.kyoto-u.ac.jp


Sponsor or person

Institute

Kyoto University

Institute

Department

Personal name



Funding Source

Organization

The Laerdal foundation for acute Medicine

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Norway


Other related organizations

Co-sponsor


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

2009 Year 06 Month 30 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

Date of protocol fixation

2009 Year 03 Month 18 Day

Date of IRB


Anticipated trial start date

2009 Year 04 Month 01 Day

Last follow-up date

2013 Year 03 Month 01 Day

Date of closure to data entry

2013 Year 06 Month 01 Day

Date trial data considered complete

2013 Year 12 Month 01 Day

Date analysis concluded

2014 Year 03 Month 01 Day


Other

Other related information



Management information

Registered date

2009 Year 06 Month 10 Day

Last modified on

2009 Year 06 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002514


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name