UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of setting upper limit of chest compression depth for the general public: A randomized controlled trial.
Title of the study (Brief title)	Effect of setting upper limit of chest compression depth for the general public: A randomized controlled trial.
Region	Japan

Condition
Condition	Out-of-hospital cardiac arrest
Classification by specialty	Emergency medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare the chest compression depth six months after the training between those who are trained with "push as hard as you can" or those who are trained with "push approximately 5cm and don't push over 6cm" for the general public.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Average chest compressions depth during two minutes test periods six months after the initial training.
Key secondary outcomes	During two minutes test periods immediately and six months after the initial training 1 Number of chest compressions with correct hands position. 2 Number of chest compressions with adequate recoil. 3 Total number of chest compressions 4 Average chest compressions depth (mm) 5 Hands-off time without chest compressions 6 Average number of chest compressions rate 7 Number of chest compressions with over 60mm depth

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification	YES
Dynamic allocation	NO
Institution consideration
Blocking
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Maneuver
Interventions/Control_1	Instruct chest compressions as "push as hard as you can" for 15 minutes training.
Interventions/Control_2	Instruct chest compressions as "push approximately 5cm, but don't push over 6cm" for 15minutes training.
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	65 years-old >
Gender	Male and Female
Key inclusion criteria	General public who lives in Japan and speaks Japanese.
Key exclusion criteria	1. The health care providers; doctor, registered nurse, assistant nurse, pharmacist, nutrition, physical therapist, occupational therapist, medical engineering and paramedic are excluded. 2. People who have taken CPR training within six months. 3. Those who are not able to perform chest compressions because of any physical or mental disabilities.
Target sample size	65

Research contact person
Name of lead principal investigator	Chika Nishiyama
Organization	Kyoto University
Division name	Graduate school of medicine, department of critical care nursing school of human health science.
Address	53 Shogoin Kawahara-cho, Sakyo-ku, Kyoto, Japan
TEL	075-751-3950
Email	nishiyama.chika.3n@kyoto-u.ac.jp

Public contact
Name of contact person	Makiko Sano
Organization	Kyoto University
Division name	Graduate school of medicine, department of critical care nursing school of human health science.
Address	53 Shogoin Kawahara-cho, Sakyo-ku, Kyoto, Japan
TEL	075-751-3950
Homepage URL
Email	sano.makiko.36z@st.kyoto-u.ac.jp

Sponsor
Institute	Kyoto University
Institute
Department

Funding Source
Organization	Kyoto University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2017 Year 02 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 01 Month 04 Day
Anticipated trial start date	2017 Year 02 Month 01 Day
Last follow-up date	2017 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2018 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 02 Month 01 Day
Last modified on	2018 Year 08 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000029844