UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060699 |
|---|---|
| Receipt number | R000069428 |
| Scientific Title | Impact of task-sharing intervention by expert nurses skilled in ultrasound-guided peripheral intravenous catheterization for difficult venous access cases on ward nurses anxiety levels A non-randomized comparative study in surgical wards |
| Date of disclosure of the study information | 2026/02/17 |
| Last modified on | 2026/02/17 18:51:20 |
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Basic information
Public title
Effect of a task-sharing system for ultrasound-guided peripheral intravenous catheterization in difficult venous access cases on ward nurses anxiety levels
Acronym
USTask-PIVC Study (Ultrasound-guided Task-sharing for PIVC Study)
Scientific Title
Impact of task-sharing intervention by expert nurses skilled in ultrasound-guided peripheral intravenous catheterization for difficult venous access cases on ward nurses anxiety levels A non-randomized comparative study in surgical wards
Scientific Title:Acronym
UVATS-ANX Study
Region
| Japan |
Condition
Condition
Difficult peripheral venous access
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine whether task-sharing intervention by expert nurses skilled in ultrasound-guided peripheral intravenous catheterization reduces ward nurses anxiety levels in difficult venous access cases compared with usual practice.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Anxiety level regarding difficult peripheral venous access measured by Numerical Rating Scale 0-10 assessed before and after intervention
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Expert nurses with more than 500 cases of ultrasound-guided peripheral venous access and completion of specified nurse training perform ultrasound-guided peripheral intravenous catheterization as a task-sharing intervention.
Interventions/Control_2
Ward nurses manage difficult peripheral venous access cases according to usual ward practice.
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
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Nurses working in surgical wards of A General Hospital
2. Nurses with experience managing difficult peripheral venous access cases
3. Those who provided written informed consent
Key exclusion criteria
1. Nurses scheduled for ward transfer during the study period
2. Those unable to complete the questionnaire survey
3. Those deemed inappropriate by the principal investigator
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | Masashi |
| Middle name | |
| Last name | Koizumi |
Organization
Okayama Saiseikai General Hospital
Division name
Department of Nursing
Zip code
7008511
Address
2-25 Kokutaicho, Kita-ku, Okayama-shi, Okayama, Japan
TEL
0862527375
masahi470808@gmail.com
Public contact
Name of contact person
| 1st name | Masashi |
| Middle name | |
| Last name | Koizumi |
Organization
Okayama Saiseikai General Hospital
Division name
Department of Nursing
Zip code
7008511
Address
2-25 Kokutaicho, Kita-ku, Okayama-shi, Okayama, Japan
TEL
0862522211
Homepage URL
byouin@okayamasaiseikai.or.jp
Sponsor or person
Institute
Okayama Saiseikai General Hospital
Institute
Department
Personal name
Funding Source
Organization
Okayama Saiseikai General Hospital
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
Research Ethics Committee of Okayamasaiseikai General Hospital
Address
Kokutaicho, Kita-ku, Okayama-shi, Okayama, Japan
Tel
0862522211
byouin@okayamasaiseikai.or.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
| 2026 | Year | 02 | Month | 17 | 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
| 2026 | Year | 02 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | 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
| 2026 | Year | 02 | Month | 17 | Day |
Last modified on
| 2026 | Year | 02 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069428
