UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004101
Receipt number R000004810
Scientific Title Effectiveness of simplified refresher CPR training with chest compression-only CPR : a randomized controlled trial
Date of disclosure of the study information 2010/08/25
Last modified on 2012/09/26 14:30:30

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Basic information

Public title

Effectiveness of simplified refresher CPR training with chest compression-only CPR : a randomized controlled trial

Acronym

Effectiveness of simplified refresher CPR training program

Scientific Title

Effectiveness of simplified refresher CPR training with chest compression-only CPR : a randomized controlled trial

Scientific Title:Acronym

Effectiveness of simplified refresher CPR training program

Region

Japan


Condition

Condition

Cardiac arrest

Classification by specialty

Cardiology Emergency medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To compared the CPR skills one year after the training between those with and without the refresher CPR training.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

The primary outcome measures is the net number of appropriate chest compressions performed during two-minute test period one year after the training

Key secondary outcomes

One year after the training
1.Check consciousness
2.Call for help
3.Call for AED
4.Time to first chest compression
5. Number of chest compressions during two-minute test period
6. Number of chest compressions with appropriate depth during two-minute test period
7. Number of chest compressions with correct hand position during two-minute test period
8. Number of chest compressions with appropriate recoil during two-minute test period
9.Time without chest compressions
10.Tune on AED
11.Correct positioning of defibrillator pad
12.clear self and area
13. Time to first AED defibrillator
14. Awareness of CPR and AED use


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

NO

Institution consideration


Blocking

YES

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Maneuver

Interventions/Control_1

The refresher training course group members were given a 45-minute training program consisting of continuous chest compressions and an AED operation and 15-minute refresher training course after 6 month.

Interventions/Control_2

The control group members were given a 45-minute training program consisting of continuous chest compressions and an AED operation.

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

70 years-old >=

Gender

Male and Female

Key inclusion criteria

General public 18 years of age or older living in Japan.

Key exclusion criteria

1.Healthcare professionals(medical doctor nurse pharmacist,medicaltechnician,radiografher,occupational thrapist,physical therapist,medical engineer,paramedic)
2.Students majoring healthcare

Target sample size

120


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Iwami Taku

Organization

Kyoto University

Division name

Health service

Zip code


Address

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

TEL

075-753-2431

Email



Public contact

Name of contact person

1st name
Middle name
Last name Okamoto Yoshio

Organization

Okayama University

Division name

Pediatrics

Zip code


Address

Shikata-cho. Kita-ku,Okayama.700-8558

TEL

086-2325-6643

Homepage URL


Email



Sponsor or person

Institute

Kyoto University

Institute

Department

Personal name



Funding Source

Organization

Grant-in-Aid for Health and Labour Sciences Research Grants (H21-Shinkin-001) from the Ministry of Health, Labour and Welfare.

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor

Kyoto University

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

京都大学  Kyoto University


Other administrative information

Date of disclosure of the study information

2010 Year 08 Month 25 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

Completed

Date of protocol fixation

2010 Year 08 Month 25 Day

Date of IRB


Anticipated trial start date

2010 Year 09 Month 01 Day

Last follow-up date

2012 Year 04 Month 01 Day

Date of closure to data entry

2012 Year 06 Month 01 Day

Date trial data considered complete

2012 Year 09 Month 01 Day

Date analysis concluded

2012 Year 12 Month 01 Day


Other

Other related information



Management information

Registered date

2010 Year 08 Month 25 Day

Last modified on

2012 Year 09 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004810


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name