An interventional study of Veinlite PEDI2 in Catheterization, Peripheral, Catheters, Indwelling and Catheter Complications, sponsored by Dokuz Eylul University. Completed at 1 site in Turkey. Open to participants aged 1 Month to 6 Years. Per ClinicalTrials.gov, last updated 2025-06-05.
Sponsored by Dokuz Eylul University · Not applicable, Interventional, and Prevention
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.
Dokuz Eylul University is the lead sponsor of 252 studies on the registry; 32 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Device: Veinlite PEDI2
no vein imaging device was used before cathater insertion
The Veinlite PEDI2 used before the catheter insertion.
PIC insertion success
first-attempt PIC insertion success
Time frame: through the PIC insertion
procedural time
procedural time for successful PIC insertion
Time frame: through the PIC insertion
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
Time frame: FLACC score evaluated 3 minutes after the PIC insertion
PIC indwelling time
PIC stay 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)
This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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Dokuz Eylul University