Catheterization, PeripheralVeinimagingNCT07006038
Vein Imaging Device on First-Attempt Success in Peripheral Intravenous Catheter Insertion
A study testing Veinlite PEDI2 in people with Catheterization, Peripheral and Catheters, Indwelling, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to evaluate the impact of vein visualization device on catheter placement success and catheter-related complications during peripheral IV catheter insertion in pediatric emergency departments. Read more about this study
- Who is it for?
- Ages 1 month to 6 years
- Conditions the study is for
- Catheterization, Peripheral, Catheters, Indwelling, Catheter Complications
- What is being tested?
- Veinlite PEDI2
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 206 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 May 2023to 30 Jan 2024
- 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 month to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- The physician must inform them that PIC must be inserted to administer medication and fluids
- The parent must voluntarily agree to participate in the study, consent form must be obtained from the parent
Who cannot join
- The child presenting to the pediatric emergency department must be in shock or severely dehydrated, requiring urgent intervention
- No need for PIC
- Presence of a central venous catheter (since there will be no need for PIC)
- Selection of the lower extremities for PIC placement (since they may experience more pain and complication)
- Use of sedatives or analgesics before the PIC procedure (at least 4 hours before)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Vein Imaging Device on First-Attempt Success and Catheter Complications in Peripheral Intravenous Catheter Insertion
This study aimed to evaluate the impact of vein visualization device on catheter placement success and catheter-related complications during peripheral IV catheter insertion in pediatric emergency departments. This randomized controlled trial compares the group using a vein visualization device with the group using the standard method.
Read the detailed description
There were two groups in this study: the vein imaging device and the control group.
The children to be included in this study consisted of pediatric patients who were admitted to the PED. There were two groups in this study: the vein imaging device and the control group. If the physician requested a peripheral intravenous catheter (PIC), the vein imaging device was applied to increase the first-attempt success of the PIC in one group. In addition, there was a control group in which any device was not used. One trained nurse who was a PhD student enrolled the participants who met the eligibility criteria.
The patients who were scheduled for PIC insertion were allocated to groups according to the randomization scheme. After providing information to the child and the parent, the investigator obtained consent from the parent, and the group assignment was determined. The patients in the control group did not receive any additional interventions and were observed during the PIC insertion after obtaining consent.
The PIC procedure time started when the tourniquet connected. In the vein imaging device and the control groups, communication with the child was maintained using the questions mentioned above during the procedure by the researcher nurse. When the phlebotomist nurse decided on the insertion site for the PIC, the PIC was attempted. If the PIC was inserted on the first attempt, the PIC procedure time stopped. If not, when the PIC was successfully inserted, the PIC procedure time was stopped. The PIC insertion time was recorded in minutes for successful PIC insertion. After the PIC insertion area was closed with dressing and the materials were collected, the child's pain was assessed by the PED nurse with the FLACC pain scale.
Complication signs and symptoms are monitored in the PIC area. If the PIC is to be removed for any reason, the reason and time of removal are recorded. PIC indwelling time was recorded. If it was removed due to a complication, the PIC area was followed up by grading with infiltration, extravasation, and phlebitis scales.
- Conditions
- Catheterization, Peripheral, Catheters, Indwelling, Catheter Complications, Pain, Children
- Being tested
- Veinlite PEDI2
- Keywords
- pediatric emergency department, child, peripheral catheter, vein imaging device, pain, indwelling time
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Veinlite PEDI2Device
The Veinlite PEDI2 used before the catheter insertion.
| Study group | Role | What they receive |
|---|---|---|
| Vein imaging device group | Experimental | the PIC insertion area was visualized with the help of the device by the nurse. The vein imaging device was used before the catheter insertion attempted to view the patient's veins. Receives: Device: Veinlite PEDI2 |
| Control group | No intervention | no vein imaging device was used before cathater insertion |
What is being measured
The primary outcome is the main question the study is designed to answer.
PIC insertion success
first-attempt PIC insertion success
Measured: through the PIC insertion
procedural time
procedural time for successful PIC insertion
Measured: through the PIC insertion
Secondary outcomes (2)
PIC insertion related pain score
The FLACC (Face, Legs, Activity, Cry, Consolability) score related to the PIC 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 PIC insertion
PIC indwelling time
PIC stay time
Measured: through the PIC stay (If the PIC is to be removed for any reason, the reason and time of removal are recorded, PIC indwelling time was recorded as hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2025
- Study start30 May 2023
- Primary completion3 Jun 2023
- Study completion30 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Catheterization, PeripheralStudies 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
- Model description
- The PIC insertion area was visualized with the help of the Veinlite PEDI device by the nurse. The vein imaging device was used before the PIC attempted to view the patient's veins, and after the nurse decided on the vein, the PIC was attempted.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 206 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gülçin Özalp Gerçeker, Dokuz Eylul University
- Investigators
- Gülçin Özalp Gerçeker, Assoc. Prof., Study director, Dokuz Eylul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07006038
- Sponsor's protocol ID
- Vein Imaging-PED
- Other IDs
- 578-SBKAEK
- Acronym
- Veinimaging
- Status last verified
- May 2025
- First submitted
- 2 May 2025
- Last updated
- 5 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yildirim BG, Gerceker GO, Ulusoy E. Effect of vein imaging device use on first-attempt peripheral intravenous catheter insertion success and catheter complications in children: A randomized controlled trial. J Pediatr Nurs. 2026 Jul-Aug;89:293-300. doi: 10.1016/j.pedn.2026.04.022. Epub 2026 May 5.
PubMed 42090961
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vein Imaging Device on First-Attempt Success and Catheter Complications in Peripheral Intravenous Catheter Insertion
- ClinicalTrials.gov ID
- NCT07006038
- Acronym / sponsor ID
- Veinimaging / Vein Imaging-PED
- Conditions
- Catheterization, Peripheral, Catheters, Indwelling, Catheter Complications, Pain, Children
- Keywords
- pediatric emergency department, child, peripheral catheter, vein imaging device, pain, indwelling time
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 206 participants (actual)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Study start
- 30 May 2023 (actual)
- Primary completion
- 3 Jun 2023 (actual)
- Study completion
- 30 Jan 2024 (actual)
- First posted
- 5 Jun 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.
This study aimed to evaluate the impact of vein visualization device on catheter placement success and catheter-related complications during peripheral IV catheter insertion in pediatric emergency departments. This randomized controlled trial compares the group using a vein visualization device with the group using the standard method.
Detailed description
There were two groups in this study: the vein imaging device and the control group.
The children to be included in this study consisted of pediatric patients who were admitted to the PED. There were two groups in this study: the vein imaging device and the control group. If the physician requested a peripheral intravenous catheter (PIC), the vein imaging device was applied to increase the first-attempt success of the PIC in one group. In addition, there was a control group in which any device was not used. One trained nurse who was a PhD student enrolled the participants who met the eligibility criteria.
The patients who were scheduled for PIC insertion were allocated to groups according to the randomization scheme. After providing information to the child and the parent, the investigator obtained consent from the parent, and the group assignment was determined. The patients in the control group did not receive any additional interventions and were observed during the PIC insertion after obtaining consent.
The PIC procedure time started when the tourniquet connected. In the vein imaging device and the control groups, communication with the child was maintained using the questions mentioned above during the procedure by the researcher nurse. When the phlebotomist nurse decided on the insertion site for the PIC, the PIC was attempted. If the PIC was inserted on the first attempt, the PIC procedure time stopped. If not, when the PIC was successfully inserted, the PIC procedure time was stopped. The PIC insertion time was recorded in minutes for successful PIC insertion. After the PIC insertion area was closed with dressing and the materials were collected, the child's pain was assessed by the PED nurse with the FLACC pain scale.
Complication signs and symptoms are monitored in the PIC area. If the PIC is to be removed for any reason, the reason and time of removal are recorded. PIC indwelling time was recorded. If it was removed due to a complication, the PIC area was followed up by grading with infiltration, extravasation, and phlebitis scales.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The PIC insertion area was visualized with the help of the Veinlite PEDI device by the nurse. The vein imaging device was used before the PIC attempted to view the patient's veins, and after the nurse decided on the vein, the PIC was attempted.
| Arm | Type | Receives |
|---|---|---|
| Vein imaging device group | Experimental | Device: Veinlite PEDI2the PIC insertion area was visualized with the help of the device by the nurse. The vein imaging device was used before the catheter insertion attempted to view the patient's veins. |
| Control group | No intervention | –no vein imaging device was used before cathater insertion |
Who may qualify
- Ages
- 1 month to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- The physician must inform them that PIC must be inserted to administer medication and fluids
- The parent must voluntarily agree to participate in the study, consent form must be obtained from the parent
Key exclusion criteria (5 listed)
- The child presenting to the pediatric emergency department must be in shock or severely dehydrated, requiring urgent intervention
- No need for PIC
- Presence of a central venous catheter (since there will be no need for PIC)
- Selection of the lower extremities for PIC placement (since they may experience more pain and complication)
- Use of sedatives or analgesics before the PIC procedure (at least 4 hours before)
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 |
|---|---|---|
| Veinlite PEDI2The Veinlite PEDI2 used before the catheter insertion. | Device | Vein imaging device group |
Primary outcome
PIC insertion success
Time frame: through the PIC insertion
first-attempt PIC insertion success
procedural time
Time frame: through the PIC insertion
procedural time for successful PIC insertion
2 secondary outcomes
PIC insertion related pain score
Time frame: FLACC score evaluated 3 minutes after the PIC insertion
PIC indwelling time
Time frame: through the PIC stay (If the PIC is to be removed for any reason, the reason and time of removal are recorded, PIC indwelling time was recorded as hours)
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 5 Jun 2025.
- Derived from this study: PubMed 42090961Yildirim BG, Gerceker GO, Ulusoy E. Effect of vein imaging device use on first-attempt peripheral intravenous catheter insertion success and catheter complications in children: A randomized controlled trial. J Pediatr Nurs. 2026 Jul-Aug;89:293-300. doi: 10.1016/j.pedn.2026.04.022. Epub 2026 May 5.
Related trials for Catheterization, Peripheral
Enrolling by invitation
TruVascular Access - Ultrasound-Guided Vascular Access Study
Peripheral Venous Catheterization, Difficult Intravenous Access
Not yet recruiting
Near-Infrared Light for Peripheral Venous Catheterization in Adults With Difficult Venous Access
Difficult Venous Access
Recruiting
Comparison of the Effectiveness of Ultrasound-guided Techniques and Infrared Illumination, Compared With the Standard Approach to Peripheral Venous Line Placement in People With Difficult Venous Access
Peripheral Venous Catheterization
Recruiting
Single Lumen Midline Catheter vs Ultrasound Guided Peripheral IV as Performed by Bedside Emergency Department Registered Nurses
Difficult Vein Access, Emergency Department Patients
Enrolling by invitation
Use of Hand Extension Rubber During Intravenous Catheter Placement
Pain, Anxiety
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.
Gülçin Özalp Gerçeker, Assoc. Prof. study director
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 Veinlite PEDI2 in people with Catheterization, Peripheral and Catheters, Indwelling, run by Dokuz Eylul University 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 5 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 5 Jun 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?
PIC insertion success (time frame: through the PIC 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?
On the ClinicalTrials.gov record for NCT07006038, which also lists 1 linked publication.
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 5 Jun 2025.