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

NCT07006038 | Completed DMC

• 2 other identifiers: Vein Imaging-PED578-SBKAEK
• Study Type: interventional
• Target: 206
• Locations: 1 country
• Sites: 1

Brief 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. This randomized controlled trial compares the group using a vein visualization device with the group using the standard method.

Conditions

Catheterization, Peripheral; Catheters, Indwelling; Catheter Complications; Pain; Children

Keywords

pediatric emergency department; child; peripheral catheter; vein imaging device; pain; indwelling time

Outcome Measures

Primary Outcomes (2)

• PIC insertion success

  first-attempt PIC insertion success

  through the PIC insertion

• procedural time

  procedural time for successful PIC insertion

  through the PIC insertion

Secondary Outcomes (2)

• PIC insertion related pain score

  FLACC score evaluated 3 minutes after the PIC insertion

• PIC indwelling 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)

Study Arms (2)

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.

Device: Veinlite PEDI2

Control group

NO INTERVENTION

no vein imaging device was used before cathater insertion

Interventions

Veinlite PEDI2 DEVICE

The Veinlite PEDI2 used before the catheter insertion.

Vein imaging device group

Eligibility Criteria

• Age: 1 Month - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Dokuz Eylul University: lead

Study Sites (1)

Dokuz Eylul University

Izmir, 35100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Gülçin Özalp Gerçeker, Assoc. Prof.

  Dokuz Eylul University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The child's pain was assessed by the other non-researcher PED nurse with the FLACC pain scale.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Pediatric Nursing Department

Model Details: 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.

Study Record Dates

• First Submitted: May 2, 2025
• First Posted: June 5, 2025
• Study Start: May 30, 2023
• Primary Completion: June 3, 2023
• Study Completion: January 30, 2024
• Last Updated: June 5, 2025

Record last verified: 2025-05

Locations

TU (1)