UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061034 |
|---|---|
| Receipt number | R000069846 |
| Scientific Title | A Randomized Controlled Trial of Ultrasound-Guided Forearm Cannulation versus Landmark-Guided Dorsal Hand Cannulation in Pediatric Patients |
| Date of disclosure of the study information | 2026/04/01 |
| Last modified on | 2026/03/24 12:01:27 |
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Basic information
Public title
A Randomized Controlled Trial of Ultrasound-Guided Forearm Cannulation versus Landmark-Guided Dorsal Hand Cannulation in Pediatric Patients
Acronym
A Randomized Controlled Trial of Ultrasound-Guided Forearm Cannulation versus Landmark-Guided Dorsal Hand Cannulation in Pediatric Patients
Scientific Title
A Randomized Controlled Trial of Ultrasound-Guided Forearm Cannulation versus Landmark-Guided Dorsal Hand Cannulation in Pediatric Patients
Scientific Title:Acronym
A Randomized Controlled Trial of Ultrasound-Guided Forearm Cannulation versus Landmark-Guided Dorsal Hand Cannulation in Pediatric Patients
Region
| Japan |
Condition
Condition
pediatric peripheral intravenous infusion
Classification by specialty
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Peripheral intravenous catheterization (PIVC) in pediatric patients is a fundamental and routinely performed procedure. However, catheter failure (CF) occurs at a relatively high rate of 34-38%, leading to repeated cannulation attempts and infiltration, which increase the burden on both children and their caregivers and result in inefficient use of medical resources.
Traditionally, cannulation of dorsal hand veins has been the standard approach due to their good visibility. In recent years, however, advances in ultrasound technology have enabled cannulation of forearm veins. Despite this, no studies have directly compared CF rates between dorsal hand cannulation and ultrasound-guided forearm cannulation in pediatric patients, and standardization remains insufficient.
This study aims to optimize pediatric venous access techniques based on scientific evidence and has significant clinical relevance in clarifying their effectiveness and safety.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
To compare the incidence of catheter failure (CF) between the two techniques and to determine which is superior in terms of infusion completion rates.
Key secondary outcomes
(1) To compare the first-attempt success rate, number of insertion attempts, and catheter dwell time between the two groups.
(2) To evaluate the association between catheter failure (CF) and anatomical factors (e.g., vessel diameter, depth, and distance from joints), as well as clinical factors (e.g., age and type of infusate).
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
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
In the control group (dorsal hand vein cannulation group), cannulation is performed in the dorsal hand vein using a 24-gauge Surflo Flash catheter (Terumo Corporation) according to standard practice. The insertion site is then secured with Microfoam surgical tape and Cathereeplus, followed by immobilization using an age-appropriate pediatric splint.
Interventions/Control_2
In the intervention group (ultrasound guided forearm vein cannulation group), forearm veins are visualized using a FUJIFILM SonoSite ultrasound system with an L25 ( linear probe, and cannulation is performed using a 22 gauge Surflo Flash catheter (Terumo Corporation). The insertion site is secured with Microfoam surgical tape and Cathereeplus, as in the control group, but no splint is used.
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
| 6 | months-old | <= |
Age-upper limit
| 6 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients for whom written informed consent was obtained from a parent or legal guardian after adequate explanation of the study.
Pediatric patients aged 6 months to 6 years at the time of enrollment.
Patients who require inpatient treatment and are judged to need peripheral intravenous catheter (PIVC) infusion for at least 24 hours.
Key exclusion criteria
Patients admitted from departments other than pediatrics.
Patients with severe underlying conditions (e.g., cardiac disease, renal disease, or immunodeficiency).
Patients receiving intravenous fluids other than lactated Ringer solution with glucose or Soludem No. 2 solution.
Patients in whom peripheral intravenous access failed after two attempts.
Patients whose catheter was removed within 24 hours after initiation of infusion for medical reasons.
Patients deemed inappropriate for inclusion by the principal investigator or co-investigators.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | katsuyuki |
| Middle name | |
| Last name | yokoi |
Organization
FUJITA HEALTH UNIVERSITY OKAZAKI MEDICAL CENTER
Division name
pediatrics
Zip code
444-0827
Address
1 Gotanda, Harisaki-cho, Okazaki
TEL
81564648800
k-yokoi@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | katsuyuki |
| Middle name | |
| Last name | yokoi |
Organization
FUJITA HEALTH UNIVERSITY OKAZAKI MEDICAL CENTER
Division name
pediatrics
Zip code
444-0827
Address
1 gotanda, harisaki-cho, okazaki
TEL
81564648800
Homepage URL
k-yokoi@fujita-hu.ac.jp
Sponsor or person
Institute
FUJITA HEALTH UNIVERSITY
Institute
Department
Personal name
katsuyuki yokoi
Funding Source
Organization
no
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
fujita health university okazaki medical center
Address
1 gotanda, harisaki-cho, okazaki
Tel
81564648800
k-yokoi@fujita-hu.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
藤田医科大学岡崎医療センター
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 04 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 03 | Month | 23 | Day |
Date of IRB
| 2026 | Year | 03 | Month | 23 | Day |
Anticipated trial start date
| 2026 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 12 | 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 | 03 | Month | 24 | Day |
Last modified on
| 2026 | Year | 03 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069846
