UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056361 |
|---|---|
| Receipt number | R000063294 |
| Scientific Title | Comparison of ultrasound-guided and landmark methods for venipuncture |
| Date of disclosure of the study information | 2024/12/05 |
| Last modified on | 2026/06/09 10:36:33 |
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Basic information
Public title
Comparison of ultrasound-guided and landmark methods for venipuncture
Acronym
Comparison of ultrasound-guided and landmark methods for venipuncture
Scientific Title
Comparison of ultrasound-guided and landmark methods for venipuncture
Scientific Title:Acronym
Comparison of ultrasound-guided and landmark methods for venipuncture
Region
| Japan |
Condition
Condition
Comparison of ultrasound-guided and landmark methods for venipuncture: a randomised controlled trial.
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of ultrasound-guided venous cannulation performed by intensive care unit nurses on first-attempt cannulation success rate, number of cannulation attempts, and catheter dwell time."
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary endpoint shall be the first-time cannulation success rate.
Key secondary outcomes
The secondary outcomes will be the number of cannulation attempts, catheter dwell time, and the incidence of infiltration and extravasation.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
In the intervention group, the vein is punctured using the ultrasound-guided method, while in the non-intervention group, the vein is punctured using the landmark method to verify the initial success rate of cannulation, duration of indwelling and complications.
The intervention is only performed at the time of the first puncture.
Interventions/Control_2
In the intervention group, the vein is punctured using the ultrasound-guided method, while in the non-intervention group, the vein is punctured using the landmark method to verify the initial success rate of cannulation, duration of indwelling and complications.
The intervention is only performed at the time of the first puncture.
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
Patients aged 18 years and over who are admitted to the ICU and require fluid management from the peripheral venous tract.
Key exclusion criteria
Patients younger than 18 years of age.
If the non-intervention group cannot identify a punctureable vessel by the ultrasound-guided method, the patient is switched to ultrasound-guided puncture, and if the patient is difficult to puncture even with ultrasound guidance, the puncture is not performed and the need for a central venous catheter is discussed with the physician.
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Doi |
Organization
Tokushima University Hospital
Division name
Multidisciplinary Care Unit ICU
Zip code
770-0042
Address
2-50-1 Kuramoto-cho, Tokushima City, Tokushima Prefecture
TEL
0886339294
s.doi@kangotoku.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Doi |
Organization
Tokushima University Hospital
Division name
Multidisciplinary Care Unit ICU
Zip code
770-0042
Address
2-50-1 Kuramoto-cho, Tokushima City, Tokushima Prefecture
TEL
0886339294
Homepage URL
s.doi@kangotoku.jp
Sponsor or person
Institute
Others
Institute
Department
Personal name
Funding Source
Organization
without
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
Tokushima Univer City
Address
2-50-1 Kuramoto-cho, Tokushima City, Tokushima Prefecture
Tel
0886339294
s.doi@kangotoku.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 | 12 | Month | 05 | 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
| 2024 | Year | 09 | Month | 28 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 28 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study aims to enroll a total of 140 patients by March 31, 2028. As of June 2026, 86 patients have been enrolled.
Management information
Registered date
| 2024 | Year | 12 | Month | 04 | Day |
Last modified on
| 2026 | Year | 06 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000063294
