UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057648 |
|---|---|
| Receipt number | R000065867 |
| Scientific Title | Development of MR (Mixed Reality) for pre-use inspection support for ventilators using Hololens2 |
| Date of disclosure of the study information | 2025/04/18 |
| Last modified on | 2025/04/18 09:41:44 |
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Basic information
Public title
Development of MR (Mixed Reality) for pre-use inspection support for ventilators using Hololens2
Acronym
Development of MR (Mixed Reality) for pre-use inspection support for ventilators using Hololens2
Scientific Title
Development of MR (Mixed Reality) for pre-use inspection support for ventilators using Hololens2
Scientific Title:Acronym
Development of MR (Mixed Reality) for pre-use inspection support for ventilators using Hololens2
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Utilize AR/MR technology to improve the efficiency of ventilator inspection operations. Reduce dependence on experienced staff and verify new methods of supporting operations in medical settings. Aim to improve medical safety and optimize human resources.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of the number of calls during pre-use inspections between the control group and the MR group
Key secondary outcomes
Comparison of time spent on pre-use inspections and call content between the control group and the MR group
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Medical staff working at Yamagata University Hospital who have no experience in performing pre-use inspections of ventilators, or medical students attending classes at Yamagata University Hospital who have no experience in performing pre-use inspections of ventilators.
Key exclusion criteria
Medical staff or medical students who did not give their consent
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Tatsuya |
| Middle name | |
| Last name | Hayasaka |
Organization
Yamagata University Faculty of Medicine
Division name
Department of Anesthesia
Zip code
9909585
Address
2-2-2 Iida-nishi, Yamagata city, Yamagata 990-9585, Japan
TEL
023-628-5400
hayasakatatsuya1101@gmail.com
Public contact
Name of contact person
| 1st name | Tatsuya |
| Middle name | |
| Last name | Hayasaka |
Organization
Yamagata University Faculty of Medicine
Division name
Department of Anesthesia
Zip code
9909585
Address
2-2-2 Iida-nishi, Yamagata city, Yamagata 990-9585, Japan
TEL
023-628-5400
Homepage URL
hayasakatatsuya1101@gmail.com
Sponsor or person
Institute
Yamagata Universal Faculty of Medcine
Institute
Department
Personal name
Funding Source
Organization
Department of Anesthesiology, Yamagata University Faculty of Medicine
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
The Ethical Review Committee of Yamagata University Faculty of Medicine
Address
2-2-2, iida-nishi, Yamagata City, Yamagata 990-9585, Japan
Tel
0236285015
ikekenkyu@jm.kj.yamagata-u.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
| 2025 | Year | 04 | Month | 18 | 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
30
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
Completed
Date of protocol fixation
| 2022 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 09 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 10 | Day |
Last follow-up date
| 2025 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Research Background and Objectives
When clinical engineers with limited experience are responsible for pre-use inspections of ventilators during night shifts, holidays, and other irregular working hours, there are issues with safety and efficiency. This study aims to introduce HoloLens 2, which utilizes AR/MR technology, to reduce the number of calls for assistance from experienced staff and achieve efficient and safe work performance.
Research Methods
Participants: Medical staff or medical students with no prior experience in pre-use inspections of ventilators
Procedure:
Conduct a 5-minute lecture on pre-use inspections for participants
Participants are randomly assigned to a Control group and an MR group, and perform the inspection using prepared manuals
The Control group uses a document manual, while the MR group uses a HoloLens 2 projected manual
Evaluation criteria: Time spent on pre-use inspection, number of calls, and content of calls
Statistical analysis: Significance level P<0.05
Management information
Registered date
| 2025 | Year | 04 | Month | 18 | Day |
Last modified on
| 2025 | Year | 04 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065867
