Randomized Controlled Trial to Evaluate the Efficacy of Normal Saline Flushes at 12 and 24 Hours Intervals in Maintaining Peripheral Intravenous Catheters Patency
Overview
- Phase
- Phase 3
- Intervention
- Normal saline
- Conditions
- Pain
- Sponsor
- IRCCS Burlo Garofolo
- Enrollment
- 400
- Locations
- 1
- Primary Endpoint
- Number of participants with peripheral intravenous catheter patency
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
Children admitted in a ward often require a peripheral intravenous catheter to provide access for administration of medications, nutrients, fluids, blood products. Vascular access in children is a frequent and stressful procedure that should be performed as infrequently as possible in order to reduce the child's pain experience and the child's and family's level of distress. The maintenance of patency of indwelling catheters is therefore relevant to minimize need for replacement and children discomfort.
Recent studies investigated the most effective and safe method of maintaining peripheral intravenous lock (peripheral IVL) in children. Most of these studies focused primary on the use of heparin versus saline flushes, showing similar efficacy of the two approaches.
To the best of the investigators knowledge no study addressed the issue of the optimal flushing frequency of normal saline . The aim of this study was to evaluate the efficacy of normal saline flushes, at 12 and 24 hours intervals.
Investigators
Ronfani Luca
MD, PhD
IRCCS Burlo Garofolo
Eligibility Criteria
Inclusion Criteria
- •age between 1 and 17 years
- •peripheral intravenous catheter 22 G or 24 G
- •need to maintain the access for at least 24 hours without infusion
Exclusion Criteria
- •need for continuous infusion therapy
- •programmed therapy
Arms & Interventions
Flushing every 24 hours
Flushing with positive pressure with normal saline every 24 hours
Intervention: Normal saline
Flushing every 24 hours
Flushing with positive pressure with normal saline every 24 hours
Intervention: Flushing with positive pressure
Flushing every 24 hours
Flushing with positive pressure with normal saline every 24 hours
Intervention: MicroClave ICU Medica
Flushing every 12 hours
Flushing with positive pressure with normal saline every 12 hours
Intervention: Flushing with positive pressure
Flushing every 12 hours
Flushing with positive pressure with normal saline every 12 hours
Intervention: Normal saline
Flushing every 12 hours
Flushing with positive pressure with normal saline every 12 hours
Intervention: MicroClave ICU Medica
Outcomes
Primary Outcomes
Number of participants with peripheral intravenous catheter patency
Time Frame: Until catheter use (i.e. drug infusion) or removal (catether related complication or no further need of use), with an expected avarage of 48 hours
Patency was defined as the possibility of flushing the cannula with a 3 ml Becton Dickinson syringe filled with 3 ml of normal saline in less than 20 seconds without resistance at infusion, pain or erythema
Secondary Outcomes
- Number of participants with skin redness(Until catheter use (i.e. drug infusion) or removal (catether related complication or no further need of use), with an expected avarage of 48 hours)
- Number of participants with blood extravasation(Until catheter use (i.e. drug infusion) or removal (catether related complication or no further need of use), with an expected avarage of 48 hours)
- Number of participants with pain(Until catheter use (i.e. drug infusion) or removal (catether related complication or no further need of use), with an expected avarage of 48 hours)
- Number of participants with swelling(Until catheter use (i.e. drug infusion) or removal (catether related complication or no further need of use), with an expected avarage of 48 hours)