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

The Effect of Care Bundle in Preventing the Frequency of Peripheral Intravenous Catheter-Related Infiltration and Phlebitis in the Pediatric Emergency Department: A Quasi-Experimental Study

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.

Study Overview

• Status: Completed
• Conditions: Phlebitis; Pediatrics; Infiltration; Intravenous; Intravenous Catheters
• Intervention / Treatment: Behavioral: Care Bundle for PIVC Management

Detailed Description

This study was conducted in the Pediatric Emergency Department of Dr. Sadi Konuk Education and Research Hospital, involving 200 pediatric patients, with 100 in the intervention group and 100 in the control group. The intervention group received a care bundle, which included education on peripheral intravenous catheter management, hand hygiene, aseptic techniques, and the use of antiseptic solutions (2% chlorhexidine and 70% alcohol). The control group received standard care according to routine practice. The incidence of infiltration and phlebitis was compared between the groups, with data collected using the Visual Infusion Phlebitis Assessment Scale (VIPAS) and Pediatric Peripheral Intravenous Infiltration Scale (PPIIS).

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Istanbul, Turkey (Türkiye)
    • Dr. Sadi Konuk Eğitim ve Araştırma Hastanesi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group (Care Bundle); 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; 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.
No Intervention: Control Group (Standard Care); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
First Attempt Success Rate for PIVC Insertion	The percentage of successful PIVC insertions on the first attempt.	Procedure (During initial PIVC insertion attempt.)
Number of PIVC Insertions	The total number of PIVC insertion attempts for each patient. Assessment Method: Clinical record review.	At the time of PIVC insertion procedure
Nurse Adherence to Care Bundle Protocol	The degree to which nurses adhere to the care bundle protocol (hand hygiene, aseptic techniques, antiseptic use, etc.). Assessment Method: Adherence checklists and observation by researchers	At the time of PIVC insertion procedure

Collaborators and Investigators

• Sponsor: Istanbul University - Cerrahpasa

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Actual): June 1, 2024
• Study Completion (Actual): May 12, 2025

Study Registration Dates

• First Submitted: June 10, 2026
• First Submitted That Met QC Criteria: June 14, 2026
• First Posted (Actual): June 16, 2026

Study Record Updates

• Last Update Posted (Actual): June 16, 2026
• Last Update Submitted That Met QC Criteria: June 14, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Infiltration; Phlebitis; Care Bundle; Peripheral Intravenous Catheter; Nurse Education; Pediatric Emergency
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Vasculitis; Phlebitis; Therapeutics; Patient Care Bundles
• Other Study ID Numbers: GizemPIVC2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: A decision on sharing individual participant data will be made once the study is completed and analyzed. Ethical considerations will guide this decision.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No