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

NCT02221024 | Completed Phase 3

• 1 other identifier: RC 10/11
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Keywords

Peripheral intravenous catheter; Peripheral intravenous lock; Normal saline; Patency; Management; of peripheral; intravenous catheter

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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 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 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

Study Arms (2)

Flushing every 24 hours

EXPERIMENTAL

Flushing with positive pressure with normal saline every 24 hours

Procedure: Flushing with positive pressure; Drug: Normal saline; Device: MicroClave ICU Medica

Flushing every 12 hours

ACTIVE COMPARATOR

Flushing with positive pressure with normal saline every 12 hours

Procedure: Flushing with positive pressure; Drug: Normal saline; Device: MicroClave ICU Medica

Interventions

Flushing with positive pressure PROCEDURE

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)

Flushing every 12 hours; Flushing every 24 hours

Normal saline DRUG

Also known as: Isotonic saline solution, Physiological saline solution

Flushing every 12 hours; Flushing every 24 hours

MicroClave ICU Medica DEVICE

Flushing every 12 hours; Flushing every 24 hours

Eligibility Criteria

• Age: 1 Year - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• need for continuous infusion therapy
• programmed therapy

Sponsors & Collaborators

• IRCCS Burlo Garofolo: lead

Study Sites (1)

Emergency Department, IRCCS Burlo Garofolo

Trieste, Friuli Venezia Giulia, 34137, Italy

Location

Related Publications (1)

• 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.

  PMID: 25589559 DERIVED

MeSH Terms

Conditions

Pain

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Egidio Barbi, MD

  IRCCS Burlo Garofolo, Trieste, Italy

  STUDY CHAIR

• Silvana Schreiber, RN

  IRCCS Burlo Garofolo, Trieste, Italy

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: August 12, 2014
• First Posted: August 20, 2014
• Study Start: July 1, 2011
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: August 20, 2014

Record last verified: 2014-08

Locations

IT (1)