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Completed

NCT Number: NCT07649499

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

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.

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Key information

Age range

28 day–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dr. Sadi Konuk Eğitim ve Araştırma Hastanesi

Istanbul, Turkey (Türkiye)

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. Incidence of Peripheral Intravenous Catheter-Related Infiltration

    Time frame: From the time of catheter insertion to 6 hours post-insertion

    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).

  2. Incidence of Peripheral Intravenous Catheter-Related Phlebitis

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

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

Secondary outcomes

  1. First Attempt Success Rate for PIVC Insertion

    Time frame: Procedure (During initial PIVC insertion attempt.)

    The percentage of successful PIVC insertions on the first attempt.

  2. Number of PIVC Insertions

    Time frame: At the time of PIVC insertion procedure

    The total number of PIVC insertion attempts for each patient.

    Assessment Method: Clinical record review.

  3. Nurse Adherence to Care Bundle Protocol

    Time frame: At the time of PIVC insertion procedure

    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

Sponsors and collaborators

Lead sponsor

Istanbul University - Cerrahpasa

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Jun 16, 2026
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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