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

Phase 3

Completed

• Conditions: Pain
• Interventions: Procedure: Flushing with positive pressure; Drug: Normal saline; Device: MicroClave ICU Medica

• Registration Number: NCT02221024
• Lead Sponsor: IRCCS Burlo Garofolo

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Status Verified: 2014-08
• Study First Submitted: 2014-08-12
• Study First Submitted QC: 2014-08-19
• Last Update Submitted: 2014-08-19
• Study First Posted: 2014-08-20
• Last Update Posted: 2014-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Flushing every 24 hours	MicroClave ICU Medica	Flushing with positive pressure with normal saline every 24 hours
Flushing every 24 hours	Flushing with positive pressure	Flushing with positive pressure with normal saline every 24 hours
Flushing every 12 hours	Normal saline	Flushing with positive pressure with normal saline every 12 hours
Flushing every 24 hours	Normal saline	Flushing with positive pressure with normal saline every 24 hours
Flushing every 12 hours	MicroClave ICU Medica	Flushing with positive pressure with normal saline every 12 hours
Flushing every 12 hours	Flushing with positive pressure	Flushing with positive pressure with normal saline every 12 hours

Primary Outcome Measures

Name	Time	Method
Number of participants with peripheral intravenous catheter patency	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 Outcome Measures

Name	Time	Method
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	Presence of skin redness at the site of catheter insertion at the time of nurse's evaluation
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	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
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	Any pain at the site of catheter insertion referred by patients to nurses
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	Presence of swelling in the site of catheter insertion at the time of nurse's evaluation

Trial Locations

Locations (1)

Emergency Department, IRCCS Burlo Garofolo; 🇮🇹 Trieste, Friuli Venezia Giulia, Italy