Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 578-SBKAEK | Registry Identifier | Turkish Medicines and Medical Devices Agency |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Control group | No Intervention | no vein imaging device was used before cathater insertion |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Veinlite PEDI2 | Device | The Veinlite PEDI2 used before the catheter insertion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| PIC insertion success | first-attempt PIC insertion success | through the PIC insertion |
| procedural time | procedural time for successful PIC insertion | through the PIC insertion |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | FLACC score evaluated 3 minutes after the PIC insertion |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Gülçin Özalp Gerçeker, Assoc. Prof. | Dokuz Eylul University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dokuz Eylul University | Izmir | 35100 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42090961 | Derived | 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 May 5;89:293-300. doi: 10.1016/j.pedn.2026.04.022. Online ahead of print. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
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.
Not provided
Not provided
The child's pain was assessed by the other non-researcher PED nurse with the FLACC pain scale.
| PIC indwelling time | PIC stay time | 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) |