Dr. Sadi Konuk Eğitim ve Araştırma Hastanesi
Istanbul, Turkey (Türkiye)
NCT Number: NCT07649499
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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Notify Me28 day–18 year
All sexes
Interventional
Not applicable
Istanbul, Turkey (Türkiye)
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).
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)
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.
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).
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).
Time frame: Procedure (During initial PIVC insertion attempt.)
The percentage of successful PIVC insertions on the first attempt.
Time frame: At the time of PIVC insertion procedure
The total number of PIVC insertion attempts for each patient.
Assessment Method: Clinical record review.
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
Istanbul University - Cerrahpasa
Other
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
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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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