UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056119 |
|---|---|
| Receipt number | R000063038 |
| Scientific Title | Analysis of body movements and gaze distributions during ultrasound-guided puncture procedures |
| Date of disclosure of the study information | 2024/11/11 |
| Last modified on | 2024/11/11 14:11:29 |
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Basic information
Public title
Analysis of body movements and gaze distributions during ultrasound-guided puncture procedures
Acronym
Analysis of body movements and gaze distributions during ultrasound-guided puncture procedures
Scientific Title
Analysis of body movements and gaze distributions during ultrasound-guided puncture procedures
Scientific Title:Acronym
Analysis of body movements and gaze distributions during ultrasound-guided puncture procedures
Region
| Japan |
Condition
Condition
ultrasound-guided puncture procedures
Classification by specialty
| Anesthesiology | Emergency medicine | Intensive care medicine |
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We verified the hypothesis "In a simulation environment using a mannequin for medical procedure training, the movements and usage of the upper body, arms, and hands, as well as head and eye movements, when performing an ultrasound-guided puncture procedure on the mannequin vary depending on the practitioner's level of expertise."
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Amount of eye movement and focal depth during ultrasound-guided puncture procedures
Key secondary outcomes
Movement of the upper limbs and head during ultrasound-guided puncture procedures
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
a) Doctors, Nurse Practioner, and Registered Action Nurse who work at St. Marianna University Hospital and its branch hospitals
b) Those who have experience with ultrasound-guided puncture procedures on patients
c) Those who have read the attached explanation, understand the basic purpose of this study, and wish to voluntarily participate
d) Those who have received a sufficient explanation of their participation in this study and have given their voluntary written consent based on a sufficient understanding
Key exclusion criteria
a) In case of the principal investigator or co-investigator determines that the subject is unsuitable
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Soichiro |
| Middle name | |
| Last name | Inoue |
Organization
St. Marianna University School of Medicine
Division name
Department of Anesthesiology
Zip code
2168511
Address
2-16-1 Sugao, Miyamae, Kawasaki, Kanagawa, Japan
TEL
0449778111
inoues@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | Kosuke |
| Middle name | |
| Last name | Hamabe |
Organization
St. Marianna University School of Medicine
Division name
Department of Anesthesiology
Zip code
2168511
Address
2-16-1 Sugao, Miyamae, Kawasaki, Kanagawa, Japan
TEL
0449778111
Homepage URL
k2hamabe@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
St. Marianna University School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
St. Marianna University School of Medicine
Address
2-16-1 Sugao, Miyamae, Kawasaki, Kanagawa, Japan
Tel
0449778111
chikenjimu@marianna-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 | 11 | 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 | 08 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 11 | Day |
Anticipated trial start date
| 2024 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
No special notes
Management information
Registered date
| 2024 | Year | 11 | Month | 11 | 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=R000063038
