UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051127 |
|---|---|
| Receipt number | R000058309 |
| Scientific Title | Efficacy of the continuous resuscitation training with the gap period due to the COVID-19 pandemic |
| Date of disclosure of the study information | 2023/05/22 |
| Last modified on | 2023/05/22 21:05:27 |
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Basic information
Public title
The study of the efficacy of BLS training
Acronym
BLS: Basic Life Support
Scientific Title
Efficacy of the continuous resuscitation training with the gap period due to the COVID-19 pandemic
Scientific Title:Acronym
COVID-19: Coronavirus disease 2019
Region
| Japan |
Condition
Condition
Evaluate the effects of simulation education at our institute in cardiac arrest resuscitation
Classification by specialty
| Medicine in general | Emergency medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Staff responded to the annual survey questionnaires followed by monthly training in Basic Life Support/ Advanced Cardiovascular Life Support (BLS/ACLS) and Immediate Cardiac Life Support (ICLS) of the Japanese Association for Acute Medicine (JAAM) in 2016, 2017, and 2018. Additionally, the in-house training was implemented in 2019 without post-assessment followed by training suspension in 2020 under the COVID-19 pandemic. The last delivery of survey questionnaires was in late 2020 for KAP retention measurement.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Continuous training enhances not only the BLS/ACLS/ICLS KAP of trainees but also their untrained colleagues.
Key secondary outcomes
The training likely had the same efficacy as the CPR experience.
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
| 20 | years-old | < |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Staff members were working at the timepoints of questionaire deliveries in early 2017, 2018, 2019, and 2021.
Key exclusion criteria
Inadequate responded questionnaires
Target sample size
1500
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Moriguchi |
Organization
University of Yamanashi
Division name
Emergency & Critical Care Medicine Department, Graduate School of Medicine, Faculty of Medicine
Zip code
409-3898
Address
1110 Shimokato, Chuo city, Yamanashi Prefecture, Japan
TEL
+81-55-273-9812
tmoriguchi@yamanashi.ac.jp
Public contact
Name of contact person
| 1st name | Que |
| Middle name | N.N. |
| Last name | Tran |
Organization
University of Yamanashi
Division name
Emergency & Critical Care Medicine Department, Graduate School of Medicine, Faculty of Medicine
Zip code
409-3898
Address
1110 Shimokato, Chuo city, Yamanashi Prefecture, Japan
TEL
+81-55-273-9812
Homepage URL
g19ddm19@yamanashi.ac.jp
Sponsor or person
Institute
University of Yamanashi
Institute
Department
Personal name
Funding Source
Organization
not applicable
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Yamanashi
Address
1110 Shimokato, Chuo city, Yamanashi Prefecture, Japan
Tel
+81-55-273-9812
med-admin@yamanashi.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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 05 | Month | 22 | Day |
Related information
URL releasing protocol
https://youtu.be/xZX34D9ghFg
Publication of results
Unpublished
Result
URL related to results and publications
https://youtu.be/xZX34D9ghFg
Number of participants that the trial has enrolled
6588
Results
The mean self-efficacy level of knowledge, attitude, and practice increased over time, particularly, that of trained people was three-fold of untrained people. Trainees having no cardiopulmonary resuscitation experience gained the basic-life-support keypoint as high as untrained counterparts having three-time cardiopulmonary-resuscitation experience. Training suspension lessened the knowledge, attitude, and practice in both groups.
Results date posted
| 2023 | Year | 05 | Month | 22 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The number of female participants was almost twice that of their male counterparts; the average age group of the participants was the 40s.
Participant flow
The percentage of trainees annually took account for less than ten percent with the declining trend that has a possibility to reason by the motivation decrease of trainees for the next year training after acquiring some certain basic-life-support knowledge ans skills from this attendance, the post-assessment rates were over seventy percent.
Adverse events
not applicable
Outcome measures
Enhancing BLS/ACLS/ICLS KAP through continuous training not only benefits trained attendants but also their untrained colleagues. The training likely had the same efficacy as the CPR experience. In contrast, the disruption of training due to COVID-19 decreased KAP retention.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 01 | Month | 11 | Day |
Date of IRB
| 2017 | Year | 01 | Month | 11 | Day |
Anticipated trial start date
| 2017 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The self-assessment questionnaires were scored by survey participants including BLS/ACLS/ICLS training attendants and non-attendants. The self-efficacy level of the BLS/ACLS/ICLS KAP of survey respondents was analyzed using a five-point Likert scale.
Management information
Registered date
| 2023 | Year | 05 | Month | 22 | Day |
Last modified on
| 2023 | Year | 05 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058309
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