UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046701 |
|---|---|
| Receipt number | R000053278 |
| Scientific Title | Development of Augmented Reality (AR) to support epidural anesthesia using 3DCT |
| Date of disclosure of the study information | 2022/02/12 |
| Last modified on | 2022/07/01 13:44:09 |
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Basic information
Public title
Development of Augmented Reality (AR) to support epidural anesthesia using 3DCT
Acronym
Development of Augmented Reality (AR) to support epidural anesthesia using 3DCT
Scientific Title
Development of Augmented Reality (AR) to support epidural anesthesia using 3DCT
Scientific Title:Acronym
Development of Augmented Reality (AR) to support epidural anesthesia using 3DCT
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate whether the accuracy of epidural anesthesia can be improved by using AR technology to visualize the spine in real time during epidural anesthesia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Time spent for epidural anesthesia and number of punctures in Control group, Semi AR group and AR group
Key secondary outcomes
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
Student doctors with no experience in epidural anesthesia at Yamagata University Hospital
Key exclusion criteria
Student Doctor who did not agree
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
| 2022 | Year | 02 | Month | 12 | 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
Completed
Date of protocol fixation
| 2022 | Year | 02 | Month | 12 | Day |
Date of IRB
| 2022 | Year | 02 | Month | 04 | Day |
Anticipated trial start date
| 2022 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We hypothesized that using Augmented Reality (AR) technology to project the spinal AR on the patient's back during epidural anesthesia would make the procedure smoother. The purpose of this study is to develop an epidural anesthesia support AR that will improve the accuracy of epidural anesthesia compared to standard techniques.
Student Doctors (SDs) with no experience in performing epidural anesthesia, who will receive training at Yamagata University Hospital from March 2022 to July 2022, will be targeted using an epidural practice kit (model).
A 10-minute lecture on epidural anesthesia will be given to the SDs. The SDs will then be randomly (equally) divided into the Control group, AR group, and Semi AR group. The SDs in each group will perform epidural anesthesia as described in the lecture using an epidural anesthesia practice kit (model) made of a mannequin.
The Control group will undergo epidural anesthesia as usual and then again as usual.
The AR group will perform epidural anesthesia on the back of the epidural anesthesia practice kit using a tablet device or headset-type AR glass with AR technology to visualize the spine. After that, epidural anesthesia is administered as usual.
In the Semi AR group, the spine is projected with AR on the back of the epidural anesthesia practice kit until just before the procedure, and the procedure itself is performed without using AR as a mark of merit. Then, epidural anesthesia will be performed as usual.
The difference in the accuracy of the puncture site in the intervertebral arch between the first and second puncture in the Control group, AR group, and Semi AR group will be confirmed, and the degree of mastery of epidural anesthesia will be examined. In addition, the time spent for epidural anesthesia, the number of punctures, and the degree of difficulty (on a 10-point scale) will be measured. Statistical analysis will be performed using JMP, with a significance level of P<0.05.
Management information
Registered date
| 2022 | Year | 01 | Month | 23 | Day |
Last modified on
| 2022 | Year | 07 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053278
