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

NCT ID: NCT07006038

Last Updated: 2025-06-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 206 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-30
• Study Completion Date: 2024-01-30

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Vein imaging device group

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.

Group Type: EXPERIMENTAL

Veinlite PEDI2

Intervention Type: DEVICE

The Veinlite PEDI2 used before the catheter insertion.

Control group

no vein imaging device was used before cathater insertion

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Veinlite PEDI2

The Veinlite PEDI2 used before the catheter insertion.

Intervention Type: DEVICE

Eligibility Criteria

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)

• Minimum Eligible Age: 1 Month
• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dokuz Eylul University

OTHER

Sponsor Role: lead

Responsible Party

Gülçin Özalp Gerçeker

Professor, Pediatric Nursing Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gülçin Özalp Gerçeker, Assoc. Prof.

Role: STUDY_DIRECTOR

Dokuz Eylul University

Locations

Dokuz Eylul University

Izmir, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

578-SBKAEK

Identifier Type: REGISTRY

Identifier Source: secondary_id

Vein Imaging-PED

Identifier Type: -

Identifier Source: org_study_id