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

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.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Drug: Normal saline; Procedure: Flushing with positive pressure; Device: MicroClave ICU Medica

• Study Type: Interventional
• Enrollment (Actual): 400
• Phase: Phase 3

Contacts and Locations

Study Locations

• Italy
  • Friuli Venezia Giulia
    • Trieste, Friuli Venezia Giulia, Italy, 34137
      • Emergency Department, IRCCS Burlo Garofolo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Flushing every 24 hours; Flushing with positive pressure with normal saline every 24 hours	Drug: Normal saline; Other Names: Isotonic saline solution; Physiological saline solution; 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); Device: MicroClave ICU Medica
Active Comparator: Flushing every 12 hours; Flushing with positive pressure with normal saline every 12 hours	Drug: Normal saline; Other Names: Isotonic saline solution; Physiological saline solution; 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); Device: MicroClave ICU Medica

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with peripheral intravenous catheter patency	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	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with blood extravasation	Presence of blood extravasation in the site of catheter insertion, defined as the presence of changes in the site's appearence and temperature (i.e. edema, blanching, coolness) at the time of nurse's evaluation	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	Any pain at the site of catheter insertion referred by patients to nurses	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 skin redness	Presence of skin redness at the site of catheter insertion at the time of nurse's evaluation	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	Presence of swelling in the site of catheter insertion at the time of nurse's evaluation	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

Collaborators and Investigators

• Sponsor: IRCCS Burlo Garofolo
• Investigators: Study Director: Silvana Schreiber, RN, IRCCS Burlo Garofolo, Trieste, Italy

Publications and helpful links

General Publications

• Schreiber S, Zanchi C, Ronfani L, Delise A, Corbelli A, Bortoluzzi R, Taddio A, Barbi E. Normal saline flushes performed once daily maintain peripheral intravenous catheter patency: a randomised controlled trial. Arch Dis Child. 2015 Jul;100(7):700-3. doi: 10.1136/archdischild-2014-307478. Epub 2015 Jan 14.

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Actual): September 1, 2013
• Study Completion (Actual): September 1, 2013

Study Registration Dates

• First Submitted: August 12, 2014
• First Submitted That Met QC Criteria: August 19, 2014
• First Posted (Estimate): August 20, 2014

Study Record Updates

• Last Update Posted (Estimate): August 20, 2014
• Last Update Submitted That Met QC Criteria: August 19, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Keywords: Management; Normal saline; Patency; intravenous catheter; Peripheral intravenous catheter; Peripheral intravenous lock; of peripheral
• Additional Relevant MeSH Terms: Pharmaceutical Solutions
• Other Study ID Numbers: RC 10/11