The Effect of Care Bundle in Preventing the Frequency of Peripheral Intravenous Catheter-related Infiltration and Phlebitis in the Pediatric Emergency Department

NCT07649499 | Completed

• 1 other identifier: GizemPIVC2025
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

This quasi-experimental study evaluates the effectiveness of a care bundle in preventing peripheral intravenous catheter (PIVC)-related infiltration and phlebitis in pediatric emergency department patients. The care bundle includes interventions such as nurse education, hand hygiene, aseptic techniques, and the use of antiseptic solutions (2% chlorhexidine and 70% alcohol) for PIVC insertion and maintenance. The study compares the incidence of infiltration and phlebitis between the intervention and control groups.

Conditions

Infiltration; Intravenous; Phlebitis; Pediatrics; Intravenous Catheters

Keywords

Peripheral Intravenous Catheter; Care Bundle; Infiltration; Phlebitis; Pediatric Emergency; Nurse Education

Outcome Measures

Primary Outcomes (2)

• Incidence of Peripheral Intravenous Catheter-Related Infiltration

  The primary outcome is the incidence of PIVC-related infiltration in pediatric patients. Infiltration will be assessed using the Pediatric Peripheral Intravenous Infiltration Scale (PPIIS).

  From the time of catheter insertion to 6 hours post-insertion

• Incidence of Peripheral Intravenous Catheter-Related Phlebitis

  the incidence of PIVC-related phlebitis. Phlebitis will be assessed using the Visual Infusion Phlebitis Assessment Scale (VIPAS).

  From the time of catheter insertion to 6 hours post-insertion.

Secondary Outcomes (3)

• First Attempt Success Rate for PIVC Insertion

  Procedure (During initial PIVC insertion attempt.)

• Number of PIVC Insertions

  At the time of PIVC insertion procedure

• Nurse Adherence to Care Bundle Protocol

  At the time of PIVC insertion procedure

Study Arms (2)

Intervention Group (Care Bundle)

EXPERIMENTAL

The intervention group will receive a care bundle consisting of the following: Nurse Education on peripheral intravenous catheter (PIVC) management. Hand Hygiene and adherence to aseptic techniques during PIVC insertion. Use of 2% chlorhexidine and 70% alcohol antiseptic solutions for PIVC insertion. Hydrocolloid transparent adhesive bandage for stabilization of the catheter. Nurses will avoid performing more than two attempts for PIVC insertion. Aseptic technique will be strictly followed during PIVC insertion and maintenance.

Behavioral: Care Bundle for PIVC Management

Control Group (Standard Care)

NO INTERVENTION

The control group will receive standard care as per routine practice in the pediatric emergency department: Standard peripheral intravenous catheter (PIVC) insertion procedures as performed by clinical staff. No additional interventions such as nurse education or the specific antiseptic solutions or stabilization methods will be applied.

Interventions

Care Bundle for PIVC Management BEHAVIORAL

The intervention group will receive a care bundle designed to reduce peripheral intravenous catheter (PIVC)-related complications (infiltration and phlebitis). The bundle includes the following components: Nurse Education: Training on PIVC management and best practices. Hand Hygiene: Emphasis on proper hand hygiene before and after each insertion and maintenance procedure. Aseptic Techniques: Strict adherence to aseptic technique during PIVC insertion and maintenance. Antiseptic Solutions: Use of 2% chlorhexidine and 70% alcohol for skin preparation and catheter insertion. Stabilization: Use of hydrocolloid transparent adhesive bandages for catheter fixation to prevent dislodgement and reduce irritation. Insertion Attempts: Limiting the number of attempts to a maximum of two to reduce trauma to the insertion site. Monitoring and Documentation: Regular assessment of the PIVC site for complications and accurate documentation by nursing staff.

Intervention Group (Care Bundle)

Eligibility Criteria

• Age: 28 Days - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Children admitted to the Pediatric Emergency Department
• First-time peripheral intravenous catheter (PIVC) insertion Ages between 28 days to 18 years
• At least 6 hours of observation after catheter insertion
• Fluid administration in the observation area (e.g., 5% dextrose + 0.45% NaCl + 5/10 cc potassium)
• Written informed consent obtained from parents/legal guardians
• Children willing to participate in the study

You may not qualify if:

• Children with skin problems (e.g., epidermolysis bullosa)
• Children allergic to products used in the care bundle
• Children who have undergone procedures that could cause catheter displacement or infiltration (e.g., lumbar puncture) Children with chronic vascular issues (e.g., vasculitis, hematologic disorders, congenital vascular anomalies)
• Children transferred to intensive care or another department after PIVC insertion
• Children with clinical conditions that prevent standard care bundle application (e.g., extreme agitation, inability to immobilize extremities)

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Dr. Sadi Konuk Eğitim ve Araştırma Hastanesi

Istanbul, Turkey (Türkiye)

Location

Related Publications (1)

• Suliman M, Saleh W, Al-Shiekh H, Taan W, AlBashtawy M. The Incidence of Peripheral Intravenous Catheter Phlebitis and Risk Factors among Pediatric Patients. J Pediatr Nurs. 2020 Jan-Feb;50:89-93. doi: 10.1016/j.pedn.2019.11.006. Epub 2019 Nov 27.

  PMID: 31785409 BACKGROUND

MeSH Terms

Conditions

Phlebitis

Interventions

Patient Care Bundles

Condition Hierarchy (Ancestors)

Peripheral Vascular Diseases; Vascular Diseases; Cardiovascular Diseases; Vasculitis

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 10, 2026
• First Posted: June 16, 2026
• Study Start: January 1, 2024
• Primary Completion: June 1, 2024
• Study Completion: May 12, 2025
• Last Updated: June 16, 2026

Record last verified: 2026-06

Locations

TU (1)