UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055602 |
|---|---|
| Receipt number | R000063537 |
| Scientific Title | Development and Evaluation of a New Ultrasound-Guided Regional Anesthesia Training Device Using a Real-Time Needle Tracking System |
| Date of disclosure of the study information | 2024/10/01 |
| Last modified on | 2024/11/11 10:49:28 |
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Basic information
Public title
Development and Evaluation of a New Ultrasound-Guided Regional Anesthesia Training Device Using a Real-Time Needle Tracking System
Acronym
Development and Evaluation of a New Ultrasound-Guided Regional Anesthesia Training Device Using a Real-Time Needle Tracking System
Scientific Title
Development and Evaluation of a New Ultrasound-Guided Regional Anesthesia Training Device Using a Real-Time Needle Tracking System
Scientific Title:Acronym
Development and Evaluation of a New Ultrasound-Guided Regional Anesthesia Training Device Using a Real-Time Needle Tracking System
Region
| Japan |
Condition
Condition
Patients undergoing nerve block
Classification by specialty
| Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to develop a training device incorporating a real-time needle tracking system using object detection methods (YOLO) and IMU sensors, and to evaluate whether practicing with this device allows beginners to efficiently acquire the skill of accurately maintaining the needle within the ultrasound image plane.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The number of times and duration the needle disappears from the screen, IMU data (relative position and angle changes between the needle and the probe), and YOLO data (relative position and angle changes between the needle and the probe).
Key secondary outcomes
Time to reach the target within the phantom, number of needle punctures, and accuracy of target reach (linear distance from the target to the dye, and distribution area of the dye).
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are 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
Perform puncture practice on a phantom without using the new training device.
Interventions/Control_2
Perform puncture practice on a phantom using a training device that incorporates a real-time needle tracking system utilizing object detection methods (YOLO) and IMU sensors.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Medical students and healthcare staff with no prior experience in ultrasound-guided regional anesthesia (UGRA).
Key exclusion criteria
Individuals who have experience with ultrasound-guided puncture during practical training or similar activities.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Misato |
| Middle name | |
| Last name | Kurota |
Organization
Yamagata University Faculty of Medicine
Division name
Department of Anesthesiology
Zip code
9909585
Address
2-2-2 Iida-nishi, Yamagata city, Yamagata Japan
TEL
0236285400
mkurota24@med.id.yamagata-u.ac.jp
Public contact
Name of contact person
| 1st name | Misato |
| Middle name | |
| Last name | Kurota |
Organization
Yamagata University Faculty of Medicine
Division name
Department of Anesthesiology
Zip code
9909585
Address
2-2-2 Iida-nishi, Yamagata city, Yamagata Japan
TEL
0236285400
Homepage URL
mkurota24@med.id.yamagata-u.ac.jp
Sponsor or person
Institute
Yamagata University Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
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 japan
Tel
023-628-5015
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 | 10 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 09 | Month | 25 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 25 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 12 | Month | 25 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 09 | Month | 24 | Day |
Last modified on
| 2024 | Year | 11 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063537
