The Effect of Care Bundle in Preventing the Frequency of Peripheral Intravenous Catheter-related … (NCT07649499) | Clinical Trial Compass
CompletedNot Applicable
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.
Who can participate
Age range
28 Days – 18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1My child received or may need an IV catheter in the emergency department — now that this study on care bundles is completed, has the hospital or our care team adopted any of these prevention practices to reduce the risk of infiltration or phlebitis?
2What are the warning signs that my child's IV site is developing infiltration or phlebitis, and what should I do if I notice them during a visit or after we go home?
3Since this trial focused specifically on pediatric emergency department settings, does the care my child receives there differ from what they'd get in an inpatient ward, and does that affect their risk of these IV complications?
4Can you explain what a 'care bundle' actually involves in practice — for example, does it change how often staff check the IV site or how the catheter is secured — so I know what to look for and ask about during my child's treatment?
5Now that this study is complete, are there published results I can review with you to understand how much these practices actually reduced infiltration and phlebitis rates in children similar to mine?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of Peripheral Intravenous Catheter-Related Infiltration
Timeframe: From the time of catheter insertion to 6 hours post-insertion
2
Incidence of Peripheral Intravenous Catheter-Related Phlebitis
Timeframe: From the time of catheter insertion to 6 hours post-insertion.