NCT02221024

Normal Saline Flushes at 12 vs 24 Hours Intervals for Maintaining Peripheral Intravenous Catheters Patency

Randomized Controlled Trial to Evaluate the Efficacy of Normal Saline Flushes at 12 and 24 Hours Intervals in Maintaining Peripheral Intravenous Catheters Patency

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 400 (actual)
• Sponsor: IRCCS Burlo Garofolo · Academic / Other
• Sex: All
• Age: 1 Year – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pain

Interventions

Type	Name	Description
PROCEDURE	Flushing with positive pressure	Placement of a sterile plug (MicroClave ICU Medica, a neutral displacement connector) on the needle cannula and flushing with positive pressure with saline solution (BD PosiFlush XS Syringes, filled with 3 ml of saline)
DRUG	Normal saline
DEVICE	MicroClave ICU Medica

Timeline

• Start date: 2011-07-01
• Primary completion: 2013-09-01
• Completion: 2013-09-01
• First posted: 2014-08-20
• Last updated: 2014-08-20

Locations

1 site across 1 country: Italy