Vein Imaging Device on First-Attempt Success in Peripheral Intravenous Catheter Insertion

Dokuz Eylul University206 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Conditions

Catheterization, Peripheral Catheters, Indwelling Catheter Complications Pain Children

Interventions

Veinlite PEDI2DEVICE

The Veinlite PEDI2 used before the catheter insertion.

Eligibility

Sex: ALLMin age: 1 MonthMax age: 6 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * 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)

Locations (1)

Dokuz Eylul University

Izmir, Turkey (Türkiye)

Outcomes

Primary Outcomes

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

Secondary Outcomes

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)

Data from ClinicalTrials.gov

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