UMIN-CTR Clinical Trial

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
Email	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
Email	hayasakatatsuya1101@gmail.com

Sponsor
Institute	Yamagata Universal Faculty of Medcine
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053278