UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051243 |
|---|---|
| Receipt number | R000058438 |
| Scientific Title | 3DCT-based epidural anesthesia support Augmented Reality |
| Date of disclosure of the study information | 2023/06/12 |
| Last modified on | 2023/06/14 08:20:53 |
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Basic information
Public title
Comparison of accuracy between augmented and mixed reality techniques and conventional techniques for epidural anesthesia in clinical practice
Acronym
Development and Research of Epidural Anesthesia with Mixed Reality Study(DREAM study)
Scientific Title
3DCT-based epidural anesthesia support Augmented Reality
Scientific Title:Acronym
3DCT-based epidural anesthesia support Augmented Reality
Region
| Japan |
Condition
Condition
Scheduled surgery cases
Classification by specialty
| Surgery in general | Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
| Chest surgery | Obstetrics and Gynecology | Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Epidural anesthesia is the golden standard for postoperative analgesia and is a common technique used in many surgical procedures. However, epidural anesthesia is a difficult procedure, with difficulty or failure to insert an epidural catheter occurring in about 7% of cases and as high as 26% of anesthesia residents. Causes include obesity and spinal canal stenosis. In addition, difficulty in inserting an epidural catheter can cause patient distress over time. Currently, epidural anesthesia is performed blindly, relying on the senses and rules of thumb. In recent years, with the development of mixed reality (MR) technology, technologies to visualize the invisible are being used in various fields. Mixed Reality (MR) technology has been utilized in various fields to visualize what cannot be seen. We hypothesized that MR projection of the spine on the patient's back during epidural anesthesia would facilitate smooth epidural anesthesia. In a previous study, it was shown that MR imaging of the spine enabled the placement of an epidural needle in the appropriate position to epidural anesthesia using a practice phantom model kit. In this study, we will evaluate whether MR improves the accuracy of epidural anesthesia in a real-world clinical setting by comparing a standard technique (blind) epidural anesthesia group with a group in which epidural anesthesia is performed after imaging the spine using MR technology. If the accuracy of epidural anesthesia is improved by MR imaging, it will be possible to avoid difficulties in epidural catheter insertion, thereby contributing to medical treatment by reducing patient suffering and anesthesia induction time.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Number of punctures for epidural anesthesia in the Control and MR groups (number of times the direction of the needle tip was changed)
Key secondary outcomes
Puncture time, difference between predicted and post-puncture difficulty, patient satisfaction (NRS), intervertebral narrowness in difficult cases, and presence of complications.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Maneuver |
Interventions/Control_1
The spine is projected on the back of the scheduled surgical patient with MR until just before the epidural anesthesia to construct an image. The procedure itself is performed without MR, and epidural anesthesia is administered as usual.
Interventions/Control_2
Perform epidural anesthesia as usual.
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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Only for surgical patients scheduled for epidural anesthesia at Yamagata University Hospital, and only when an anesthesiologist who is not a board-certified anesthesiologist takes charge of the patient.
Key exclusion criteria
Cases in which consent was not obtained
Cases in which the anesthesiologist in charge decided not to perform epidural anesthesia
Cases in which no epidural space clearly exists according to preoperative CT or AR models
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Shun |
| Middle name | |
| Last name | Nagashima |
Organization
Yamagata University Medical School Hospital
Division name
Department of Anesthesiology
Zip code
990-2331
Address
2-2-2, Iida-Nishi, Yamagata City, Yamagata Prefecture
TEL
0236285400
ymmsn4268@gmail.com
Public contact
Name of contact person
| 1st name | Shun |
| Middle name | |
| Last name | Nagashima |
Organization
Yamagata University Medical School Hospital
Division name
Department of Anesthesiology
Zip code
990-2331
Address
2-2-2, Iida-Nishi, Yamagata City, Yamagata Prefecture
TEL
0236285400
Homepage URL
ymmsn4268@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 Prefecture
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
| 2023 | Year | 06 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 19 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 12 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 06 | Month | 02 | Day |
Last modified on
| 2023 | Year | 06 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058438
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