UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001533 |
|---|---|
| Receipt number | R000001853 |
| Scientific Title | Teaching basic life support to fourth grade medical student by senior medical student: A randomized controlled study comparing medical professional. |
| Date of disclosure of the study information | 2008/11/29 |
| Last modified on | 2011/08/27 15:38:15 |
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Basic information
Public title
Teaching basic life support to fourth grade medical student by senior medical student: A randomized controlled study comparing medical professional.
Acronym
RCT of BLS training taught by senior medical student
Scientific Title
Teaching basic life support to fourth grade medical student by senior medical student: A randomized controlled study comparing medical professional.
Scientific Title:Acronym
RCT of BLS training taught by senior medical student
Region
| Japan |
Condition
Condition
Cardiac arrest
Classification by specialty
| Cardiology | Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to compare the effect of basic life support training by senior medical student with that of by medical professionals.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The ratio of correct depth chest compression during 3 minutes continuous chest compressions, evaluated 20 week after BLS training.
Key secondary outcomes
1. Number of chest compression per minute, evaluated 20 week after BLS training.
2. Acquisition and retention of BLS knowledge, assessed using a 22 point questionnaire (P. Toner et, al. Resuscitation 2007) immediately and 20 weeks after BLS training,
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Maneuver |
Interventions/Control_1
Senior medical student teaching group = Senior medical student teach 2-hour BLS program using video materials.
Interventions/Control_2
Medical professional teaching group = Medical professional teach 2-hour BLS program using video materials.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
4 th grade medical students in Ehime University School of Medicine participating Objective Structured Clinical Examination curriculum.
Key exclusion criteria
None
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naoto Kobayashi |
Organization
Ehime University
Division name
Medical Education Center
Zip code
Address
Shitsukawa, To-on, Ehime
TEL
0899605928
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naoto Kobayashi |
Organization
Ehime University
Division name
Medical Education Center
Zip code
Address
Shitsukawa, To-on, Ehime
TEL
0899605928
Homepage URL
Sponsor or person
Institute
Ehime University
Institute
Department
Personal name
Funding Source
Organization
Research grand for students founded by Ehime University
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
Life Support Workshop in Ehime
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
| 2008 | Year | 11 | Month | 29 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.dovepress.com/getfile.php?fileID=10629
Number of participants that the trial has enrolled
Results
Percentage chest compressions with adequate depth (mean +/- SD) was 54.5% +/- 31.8% in the peer-led group and 52.4% +/- 35.6% in the professional-led group. The 95% confidence interval (CI) of difference of the means was -18.7% to 22.8%. The proportion of participants who could ensure an adequate mean compression rate was 17/23 (73.9%) in the peer-led group but only 8/22 (36.4%) in the professional-led group (P = 0.011). On the 22-point questionnaire administered 20 weeks after training, the peer-led group scored 17.2 +/- 2.3 whereas the professional-led group scored 17.8 +/- 2.0. The 95% CI of difference of the means was -1.72 to 0.57.
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
| 2008 | Year | 10 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
| 2009 | Year | 07 | Month | 01 | Day |
Date trial data considered complete
| 2009 | Year | 07 | Month | 01 | Day |
Date analysis concluded
| 2009 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2008 | Year | 11 | Month | 28 | Day |
Last modified on
| 2011 | Year | 08 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001853
| Research Plan | |
|---|---|
| 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 |
