UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055883 |
|---|---|
| Receipt number | R000063865 |
| Scientific Title | The effect of MR (mixed reality) visualization of needles and spinal cords on epidural anesthesia training: comparative evaluation using phantom models |
| Date of disclosure of the study information | 2024/11/01 |
| Last modified on | 2024/10/19 08:36:10 |
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Basic information
Public title
The effect of MR (mixed reality) visualization of needles and spinal cords on epidural anesthesia training: comparative evaluation using phantom models
Acronym
The effect of MR (mixed reality) visualization of needles and spinal cords on epidural anesthesia training: comparative evaluation using phantom models
Scientific Title
The effect of MR (mixed reality) visualization of needles and spinal cords on epidural anesthesia training: comparative evaluation using phantom models
Scientific Title:Acronym
The effect of MR (mixed reality) visualization of needles and spinal cords on epidural anesthesia training: comparative evaluation using phantom models
Region
| Japan |
Condition
Condition
Medical students who have not yet had any experience with epidural anesthesia and who have studied anatomy
Classification by specialty
| Anesthesiology | Operative medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this research is to improve the accuracy and efficiency of epidural anesthesia using mixed reality (MR) technology. Specifically, we will project MR that visualizes the spine onto the back of a phantom model, and then use a needle that can automatically follow the spine to verify whether epidural anesthesia can be performed more accurately and smoothly. This new approach will be compared with the conventional standard technique (blind) and evaluated using an epidural anesthesia practice kit (model). This study aims to demonstrate the feasibility of epidural anesthesia using MR technology and to confirm its effectiveness.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Location of needle insertion into the epidural space in the control group, spinal MR group, needle MR group, and needle spinal MR group
Key secondary outcomes
Puncture time, number of punctures, questionnaire (subject evaluation) in the control group, spinal MR group, needle MR group, and needle spinal 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
| 20 | years-old | <= |
Age-upper limit
| 99 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
For medical students who have not yet had any experience with epidural anesthesia and who have studied anatomy
Key exclusion criteria
Students who have worked in the medical field for some reason
Students who did not obtain consent
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Hiroaki |
| Middle name | |
| Last name | Toyama |
Organization
Yamagata University Faculty of Medicine
Division name
Department of Anesthesiology
Zip code
9909585
Address
2-2-2 Iida-Nishi, Yamagata City, Yamagata Prefecture, 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 University Faculty of Medicine
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
| 2024 | Year | 11 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The aim of this study is to evaluate the effectiveness of an epidural anesthesia support system using mixed reality (MR) technology. Epidural anesthesia requires a high level of skill, and if it is difficult to insert, it can cause the patient a lot of pain for a long time.
We hypothesized that using MR technology to visualize the spine and needle would make it possible to perform the procedure more accurately and smoothly.
A total of 40 participants will be divided into four groups (Control group, Needle MR group, Spine MR group, Needle Spine MR group), with 10 participants in each group. Each participant will perform the assigned group's technique once on each of two phantom models: the Easy model and the Difficult model.
The control group will perform conventional blind epidural anesthesia techniques. In the needle MR group, the participants will wear an MR headset to visualize only the needle with the automatic tracking function. In the spine MR group, only the spine of the phantom model will be visualized. In the needle spine MR group, both the needle and the spine will be visualized using MR technology.
Evaluation items include the success rate of reaching the epidural space, deviation from the target position, time required, and number of punctures. We will also collect subjective evaluations from participants regarding ease of use and difficulty.
Management information
Registered date
| 2024 | Year | 10 | Month | 19 | Day |
Last modified on
| 2024 | Year | 10 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063865
