UMIN-CTR 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

Email

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


Email

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

Email

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/ctr_e/ctr_view.cgi?recptno=R000058309


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name