UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045269 |
|---|---|
| Receipt number | R000051700 |
| Scientific Title | Near-infrared vascular imaging versus ultrasound to guide difficult peripheral intravenous catheterization, a comparative simulation study |
| Date of disclosure of the study information | 2021/09/13 |
| Last modified on | 2023/08/28 13:27:40 |
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Basic information
Public title
Near-infrared vascular imaging versus ultrasound to guide difficult peripheral intravenous catheterization, a comparative simulation study
Acronym
Near-infrared vascular imaging versus ultrasound to guide difficult peripheral intravenous catheterization, a comparative simulation study
Scientific Title
Near-infrared vascular imaging versus ultrasound to guide difficult peripheral intravenous catheterization, a comparative simulation study
Scientific Title:Acronym
Near-infrared vascular imaging versus ultrasound to guide difficult peripheral intravenous catheterization, a comparative simulation study
Region
| Japan |
Condition
Condition
Peripheral intravenous catheterization
Classification by specialty
| Pediatrics | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We compare near-infrared vascular imaging with ultrasound guidance for difficult vascular access by using a peripheral intravascular catherization simulator in simulation training setting.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Total number of catheterization trials from start to three consecutive successes.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants 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
| Device,equipment |
Interventions/Control_1
Near-infrared vascular imaging
Interventions/Control_2
Ultrasound guiding
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
| 21 | years-old | <= |
Age-upper limit
| 40 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Medical students who have no or scant experience in peripheral intravenous catheterization
Key exclusion criteria
None
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Joho |
| Middle name | |
| Last name | Tokumine |
Organization
Kyorin University Faculty of Medicine
Division name
Department of Anesthesiology
Zip code
181-8611
Address
6-20-2 Shinkawa, Mitaka-city, Tokyo, 181-8611 Japan
TEL
0422-47-5511
kawatetsujoho6996@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Shinichiro |
| Middle name | |
| Last name | Sekiguchi |
Organization
Kyorin University Faculty of Medicine
Division name
Department of Medical Education
Zip code
181-8611
Address
6-20-2 Shinkawa, Mitaka-city, Tokyo, 181-8611 Japan
TEL
0422-47-5511
Homepage URL
ssekiguchi@ks.kyorin-u.ac.jp
Sponsor or person
Institute
Kyorin University Faculty of Medicine
Department of Anesthesiology
Institute
Department
Personal name
Funding Source
Organization
Kyorin University Faculty of Medicine
Department of Anesthesiology and Department of Medical Education
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
Kyorin University School of Medicine
Address
6-20-2 Shinkawa, Mitaka-city, Tokyo, 181-8611 Japan
Tel
0422-47-5511
rec@ks.kyorin-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
杏林大学医学部（東京都）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 09 | Month | 13 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
41
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2023 | Year | 03 | Month | 24 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 08 | Month | 23 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 15 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 22 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 04 | Month | 30 | Day |
Date analysis concluded
| 2023 | Year | 04 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 08 | Month | 26 | Day |
Last modified on
| 2023 | Year | 08 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051700
