Peripheral Intravenous Catheter Bundle
deu-acil-bd
The Effect of Peripheral Intravenous Catheter Bundle on Catheter Insertion Success, Complication Development, and Procedure-Related Pain in Patients Presenting to the Pediatric Emergency Department
1 other identifier
interventional
800
1 country
1
Brief Summary
The study was designed to investigate the effects of a PIVC Bundle, which includes a vein visualization device and a vial (BD Neoflon™ Pro catheter), on catheter placement success, complications, procedure-related pain, and catheter length of stay in children aged 1-6 years who are scheduled for peripheral intravenous catheter (PIVC) insertion.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2025
CompletedFirst Submitted
Initial submission to the registry
September 24, 2025
CompletedFirst Posted
Study publicly available on registry
November 25, 2025
CompletedNovember 25, 2025
November 1, 2025
1 year
September 24, 2025
November 22, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
PIVC insertion related pain score
The FLACC (Face, Legs, Activity, Cry, Consolability) score related to the PIVC insertion. The scale is scored in a range of 0-10, with 0 representing no pain. Assessment of score: 0 = Relaxed and comfortable 1-3 = Mild discomfort 4-6 = Moderate pain 7-10 = Severe discomfort/pain
FLACC score evaluated 3 minutes after the PIVC insertion
PIVC indwelling time
PIVC stay time
immediately after the PIC intervention
Study Arms (4)
Vein Imaging Device and Vialon Catheter Group
EXPERIMENTALUsing a PIVC bundle,Vein Imaging Device, and Vialon catheters
Vein Imaging Device and Standard/Teflon Catheter Group
EXPERIMENTALUsing a PIVC bundle,Vein Imaging Device, and Teflon catheters
Vialon Catheter Group
EXPERIMENTALUsing a PIVC bundle and Vialon catheters
Standard/Teflon Catheter Group
NO INTERVENTIONUsing a PIVC bundle and Teflon catheters
Interventions
Vein Imaging Device before PIVC insertion
Vialon catheter use for PIVC insertion
Eligibility Criteria
You may qualify if:
- must be between 1 and 6 years old.
- must be inserted PIC
You may not qualify if:
- must be shock or severe dehydration, unconsciousness.
- had a central catheter.
- must be inserted at the lower extremities.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dokuz Eylul University
Izmir, 35100, Turkey (Türkiye)
Study Officials
- PRINCIPAL INVESTIGATOR
Gulcin ÖZALP GERÇEKER
Dokuz Eylul University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Prof.
Study Record Dates
First Submitted
September 24, 2025
First Posted
November 25, 2025
Study Start
February 1, 2024
Primary Completion
February 1, 2025
Study Completion
February 1, 2025
Last Updated
November 25, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will not share