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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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07649499
Enrollment
200
Registered
2026-06-16
Start date
2024-01-01
Completion date
2025-05-12
Last updated
2026-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infiltration, Intravenous, Intravenous Catheters, Pediatrics, Phlebitis

Keywords

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

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.

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).

Interventions

BEHAVIORALCare 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.

Sponsors

Istanbul University - Cerrahpasa
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
28 Days to 18 Years
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Incidence of Peripheral Intravenous Catheter-Related InfiltrationFrom the time of catheter insertion to 6 hours post-insertionThe primary outcome is the incidence of PIVC-related infiltration in pediatric patients. Infiltration will be assessed using the Pediatric Peripheral Intravenous Infiltration Scale (PPIIS).
Incidence of Peripheral Intravenous Catheter-Related PhlebitisFrom 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

MeasureTime frameDescription
First Attempt Success Rate for PIVC InsertionProcedure (During initial PIVC insertion attempt.)The percentage of successful PIVC insertions on the first attempt.
Number of PIVC InsertionsAt the time of PIVC insertion procedureThe total number of PIVC insertion attempts for each patient. Assessment Method: Clinical record review.
Nurse Adherence to Care Bundle ProtocolAt the time of PIVC insertion procedureThe 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

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 17, 2026