Pediatricdeu-acil-bdNCT07249255
Peripheral Intravenous Catheter Bundle
A study testing Vein Imaging Device and Vialon catheters in people with Pediatric and Catheter Complications, run by Gülçin Özalp Gerçeker at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 1 year to 6 years
- Conditions the study is for
- Pediatric, Catheter Complications, Catheter
- What is being tested?
- Vein Imaging Device and Vialon catheters
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2024to 1 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- must be between 1 and 6 years old.
- must be inserted PIC
Who cannot join
- must be shock or severe dehydration, unconsciousness.
- had a central catheter.
- must be inserted at the lower extremities.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the detailed description
The study sample included four groups: (1) vein visualization device (VGC) and Vialon Catheter Group, (2) VGC and Standard/Teflon Catheter Group, (3) Vialon Catheter Group, (4) Standard/Teflon Catheter Group/Control Group. Data were collected using the Socio-Demographic Data Collection Form, the Forced Intravenous Intervention Score, the PIVC Site Follow-up Form, the Infiltration Scale, the Extravasation Scale, the Phlebitis Scale, and the FLACC Pain Diagnosis Scale.
- Conditions
- Pediatric, Catheter Complications, Catheter
- Being tested
- Vein Imaging Device, Vialon catheters
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vein Imaging DeviceDevice
Vein Imaging Device before PIVC insertion
Vialon cathetersDevice
Vialon catheter use for PIVC insertion
| Study group | Role | What they receive |
|---|---|---|
| Vein Imaging Device and Vialon Catheter Group | Experimental | Using a PIVC bundle,Vein Imaging Device, and Vialon catheters Receives: Device: Vein Imaging Device; Device: Vialon catheters |
| Vein Imaging Device and Standard/Teflon Catheter Group | Experimental | Using a PIVC bundle,Vein Imaging Device, and Teflon catheters Receives: Device: Vein Imaging Device |
| Vialon Catheter Group | Experimental | Using a PIVC bundle and Vialon catheters Receives: Device: Vialon catheters |
| Standard/Teflon Catheter Group | No intervention | Using a PIVC bundle and Teflon catheters |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: FLACC score evaluated 3 minutes after the PIVC insertion
PIVC indwelling time
PIVC stay time
Measured: immediately after the PIC intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2025
- Study start1 Feb 2024
- Primary completion1 Feb 2025
- Study completion1 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PediatricStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 800 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gülçin Özalp Gerçeker
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Gülçin Özalp Gerçeker, Dokuz Eylul University
- Investigators
- Gulcin ÖZALP GERÇEKER, Principal investigator, Dokuz Eylul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07249255
- Sponsor's protocol ID
- deu-560
- Acronym
- deu-acil-bd
- Status last verified
- Nov 2025
- First submitted
- 24 Sep 2025
- Last updated
- 25 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07249255
- Acronym / sponsor ID
- deu-acil-bd / deu-560
- Conditions
- Pediatric, Catheter Complications, Catheter
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 800 participants (actual)
- Lead sponsor
- Gülçin Özalp GerçekerUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 1 Feb 2025 (actual)
- Study completion
- 1 Feb 2025 (actual)
- First posted
- 25 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study sample included four groups: (1) vein visualization device (VGC) and Vialon Catheter Group, (2) VGC and Standard/Teflon Catheter Group, (3) Vialon Catheter Group, (4) Standard/Teflon Catheter Group/Control Group. Data were collected using the Socio-Demographic Data Collection Form, the Forced Intravenous Intervention Score, the PIVC Site Follow-up Form, the Infiltration Scale, the Extravasation Scale, the Phlebitis Scale, and the FLACC Pain Diagnosis Scale.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Vein Imaging Device and Vialon Catheter Group | Experimental | Device: Vein Imaging Device, Device: Vialon cathetersUsing a PIVC bundle,Vein Imaging Device, and Vialon catheters |
| Vein Imaging Device and Standard/Teflon Catheter Group | Experimental | Device: Vein Imaging DeviceUsing a PIVC bundle,Vein Imaging Device, and Teflon catheters |
| Vialon Catheter Group | Experimental | Device: Vialon cathetersUsing a PIVC bundle and Vialon catheters |
| Standard/Teflon Catheter Group | No intervention | –Using a PIVC bundle and Teflon catheters |
Who may qualify
- Ages
- 1 year to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- must be between 1 and 6 years old.
- must be inserted PIC
Key exclusion criteria (3 listed)
- must be shock or severe dehydration, unconsciousness.
- had a central catheter.
- must be inserted at the lower extremities.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vein Imaging DeviceVein Imaging Device before PIVC insertion | Device | Vein Imaging Device and Standard/Teflon Catheter Group, Vein Imaging Device and Vialon Catheter Group |
| Vialon cathetersVialon catheter use for PIVC insertion | Device | Vein Imaging Device and Vialon Catheter Group, Vialon Catheter Group |
Primary outcome
PIVC insertion related pain score
Time frame: FLACC score evaluated 3 minutes after the PIVC insertion
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
PIVC indwelling time
Time frame: immediately after the PIC intervention
PIVC stay time
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gulcin ÖZALP GERÇEKER principal investigator
Dokuz Eylul University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vein Imaging Device and Vialon catheters in people with Pediatric and Catheter Complications, run by Gülçin Özalp Gerçeker at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PIVC insertion related pain score (time frame: FLACC score evaluated 3 minutes after the PIVC insertion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2025.