UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056509 |
|---|---|
| Receipt number | R000064568 |
| Scientific Title | Efficacy of ECMO Simulation Education for Nurses -An Exploratory Randomized Comparison Trial - |
| Date of disclosure of the study information | 2024/12/20 |
| Last modified on | 2024/12/20 10:31:28 |
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Basic information
Public title
Efficacy of ECMO Simulation Education for Nurses -An Exploratory Randomized Comparison Trial -
Acronym
ECMO-Sim
Scientific Title
Efficacy of ECMO Simulation Education for Nurses -An Exploratory Randomized Comparison Trial -
Scientific Title:Acronym
Efficacy of ECMO Simulation Education for Nurses -An Exploratory Randomized Comparison Trial -
Region
| Japan |
Condition
Condition
Unit care nurse
Classification by specialty
| Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to investigate Japanese nurses' clinical decision-making abilities in troubleshooting ECMO through ECMO simulation education and to exploratorily examine whether this education enhances the nurses' confidence in ECMO care.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The change in scores on the test (the difference between the pre-test and one month later)
Key secondary outcomes
Visual Analog Scale (VAS) for assessing confidence
Shortened version of the User Experience Questionnaire
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Two sessions of simulation education after watching the video.
Simulation Group
Location: Simulation Room
Number of Participants: 3-4 participants, 2-3 facilitators
Facilitators:
Facilitators will include physicians and clinical engineers who have undergone training with the Extracorporeal Life Support Organization (ELSO), a global leader in ECMO education, as well as nurses who have participated in ECMO training through ECMOnet, a leader in ECMO education in Japan. Additionally, certified acute and critical care nurses specializing in nursing for critically ill patients will be facilitators. The facilitators are highly trained in ECMO education and will conduct uniform simulations by practicing the simulation scenarios together before implementation.
Method:
After watching an on-demand video (Material 1) created based on the ELSO Red Book, 6th Edition, published by Extracorporeal Life Support, participants will complete two simulations per session for 4 case scenarios. The steps for each case scenario are as follows:
Briefing (2 minutes): The scenario will be introduced, and the following procedures will be explained.
Simulation (15 minutes): The simulation will focus on troubleshooting ECMO-related issues, including observation, data collection, and responding to the troubleshooting tasks. One participant will take the lead but may consult with other participants during the process. Afterward, all possible interpretations of the information gathered will be discussed.
Debriefing (10 minutes):
Interventions/Control_2
Control Group
The control group will also watch the on-demand video created based on the ELSO Red Book, 6th Edition, published by Extracorporeal Life Support, similar to the simulation group.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
To participate in this study, nurses must meet all of the following conditions:
1)Nurses belonging to units at the National Center for Global Health and Medicine (ICU, HCU,7E).
2)Nurses with at least two years of experience.
3)Nurses who have experience caring for patients on mechanical ventilation.
4)Nurses who have provided written informed consent to participate in the study.
Key exclusion criteria
Individuals who are scheduled to attend an external ECMO training during the 3-month study period.
Individuals who are scheduled to serve as facilitators.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Michiko |
| Middle name | |
| Last name | Nakano |
Organization
National Center for Global Health and Medicine
Division name
ICU
Zip code
162-8655
Address
1-21-1 Toyama Shinjuku-ku, Tokyo
TEL
03-3202-7181
minakano@hosp.ncgm.go.jp
Public contact
Name of contact person
| 1st name | Aya |
| Middle name | |
| Last name | Umeda |
Organization
National college of nursing, Japan
Division name
Adult nursing
Zip code
2040024
Address
1-2-1, Umezono, Kiyose-shi, Tokyo 2040011 JAPAN
TEL
0424952379
Homepage URL
umedaa@adm.ncn.ac.jp
Sponsor or person
Institute
National Center for Global Health and Medicine
Institute
Department
Personal name
Michiko Nakano
Funding Source
Organization
National Center for Global Health and Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Center for Global Health and Medicine Clinical Research Review Committee
Address
1-21-1, Toyama, Shinjuku-ku, Tokyo
Tel
03-3202-7181
mnakano@hosp.ncgm.go.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
| 2024 | Year | 12 | Month | 20 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 12 | Month | 06 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 06 | Day |
Anticipated trial start date
| 2024 | Year | 12 | Month | 17 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2028 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 12 | Month | 20 | Day |
Last modified on
| 2024 | Year | 12 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064568
