UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047249 |
|---|---|
| Receipt number | R000053888 |
| Scientific Title | Educational Effects of Basic Life Support training: a pilot prospective cohort study of factors related to BLS Skill retention |
| Date of disclosure of the study information | 2022/03/28 |
| Last modified on | 2024/06/25 09:16:01 |
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Basic information
Public title
Educational Effects of Basic Life Support training: a pilot prospective cohort study of factors related to BLS Skill retention
Acronym
Educational Effects of Basic Life Support training: a pilot prospective cohort study of factors related to BLS Skill retention
Scientific Title
Educational Effects of Basic Life Support training: a pilot prospective cohort study of factors related to BLS Skill retention
Scientific Title:Acronym
Educational Effects of Basic Life Support training: a pilot prospective cohort study of factors related to BLS Skill retention
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Identify the explanatory variables on the part of the participants whose BLS skills decline
Basic objectives2
Others
Basic objectives -Others
Assessment of relevance of the explanatory variables on the part of the participants to educational effectiveness /BLS skill retention
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of data of participants who attended in-hospital BLS training more than once.
Average compression depth, average compression rate, skill check sheet evaluation (score, pass /fail)
Key secondary outcomes
Evaluation of data of participants who attended in-hospital BLS training more than once.
Compression score and parameters other than the above (rate of appropriate compression recoil, rate of appropriate compression depth, total number of compressions, rate of proper compression rate, ratio of correct handposition), ventilation score and parameters (total ventilation frequency, appropriate ventilation volume percentage, hypo/hyperventilation percentage, average ventilationvolume, average inspiration time)
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Adults staff who have participated in the in-hospital BLS training session at the University of Tokyo Hospital. It targets doctors, nurses, other medical professionals and medical office staff.
Key exclusion criteria
Those who cannot do practical training in BLS.
Target sample size
570
Research contact person
Name of lead principal investigator
| 1st name | Masato |
| Middle name | |
| Last name | Eto |
Organization
Graduate School of Medicine,
The University of Tokyo,
The University of Tokyo Hospital
Division name
Department of Medical Education Studies, International Research Center for Medical Education, General Education Center
Zip code
113-0033
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-5841-3583
meto-tky@umin.ac.
Public contact
Name of contact person
| 1st name | Hiroko |
| Middle name | |
| Last name | Mori |
Organization
The University of Tokyo Hospital
Division name
General Education Center
Zip code
113-8655
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-3815-5411
Homepage URL
mori-hiroko0114@g.ecc.u-tokyo.ac.jp
Sponsor or person
Institute
Department of Medical Education Studies,
International Research Center for Medical Education,
Graduate School of Medicine,
The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
None
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
The Office for Human Research Studies(OHRS), Graduate School of Medicine and Faculty of Medicine, The University of Tokyo
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
Tel
03-5841-0818
ethics@m.u-tokyo.ac.jp
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
東京大学医学部附属病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 03 | Month | 28 | 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
Terminated
Date of protocol fixation
| 2022 | Year | 03 | Month | 07 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 07 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 04 | Day |
Last follow-up date
| 2026 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Single-centre prospective cohort study (pilot study)
The data of the participants of the in-hospital BLS class will be analyzed using the opt-out method. Analyze as longitudinal data by participating more than once.
Objective variable:
Primary endpoints: Average compression depth, average compression rate, skill check sheet evaluation (score, pass /fail)
Explanatory variable:
Age, gender, BMI (calculated from height/weight), occupation (speciality, years), experience of cardiopulmonary resuscitation, final implementation/training period (certification status))
Secondary evaluation items:
Compression score and parameters other than the above (rate of appropriate compression recoil, rate of appropriate compression depth, total number of compressions, rate of proper compression rate, ratio of correct hand position), ventilation score and parameters (total ventilation frequency, appropriate ventilation volume percentage, hypo/hyperventilation percentage, average ventilation volume, average inspiration time)
[Supplement] Depending on the participants, it is expected that there will be a mixture of people who have participated only once, twice, and three or more times. The data of participants who participated more than once will be analyzed as longitudinal data. In addition, although the following is not the main purpose of this study, the data of the participants' first training participation including only once participated will be used as cross-sectional data to identify the explanatory factors related to skill evaluation.
[Progress]
The first data collection was completed in March 2024, with 176 participants, but the study was discontinued because it became less likely that the study would be able to realistically recruit 570 participants (mainly because the large-scale training seminar that was originally scheduled according to the protocol could not be held).
Management information
Registered date
| 2022 | Year | 03 | Month | 22 | Day |
Last modified on
| 2024 | Year | 06 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053888
