UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025959 |
|---|---|
| Receipt number | R000029844 |
| Scientific Title | Effect of setting upper limit of chest compression depth for the general public: A randomized controlled trial. |
| Date of disclosure of the study information | 2017/02/01 |
| Last modified on | 2018/08/06 16:27:06 |
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Basic information
Public title
Effect of setting upper limit of chest compression depth for the general public: A randomized controlled trial.
Acronym
Effect of setting upper limit of chest compression depth for the general public: A randomized controlled trial.
Scientific Title
Effect of setting upper limit of chest compression depth for the general public: A randomized controlled trial.
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Chika Nishiyama |
Organization
Kyoto University
Division name
Graduate school of medicine, department of critical care nursing school of human health science.
Zip code
Address
53 Shogoin Kawahara-cho, Sakyo-ku, Kyoto, Japan
TEL
075-751-3950
nishiyama.chika.3n@kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Makiko Sano |
Organization
Kyoto University
Division name
Graduate school of medicine, department of critical care nursing school of human health science.
Zip code
Address
53 Shogoin Kawahara-cho, Sakyo-ku, Kyoto, Japan
TEL
075-751-3950
Homepage URL
sano.makiko.36z@st.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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
| 2017 | Year | 01 | Month | 04 | Day |
Date of IRB
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 |
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029844
| 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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| Registered date | File name |
