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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
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02221024
Enrollment
400
Registered
2014-08-20
Start date
2011-07-31
Completion date
2013-09-30
Last updated
2014-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Keywords

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

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.

Interventions

PROCEDUREFlushing 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)

DRUGNormal saline
DEVICEMicroClave ICU Medica

Sponsors

IRCCS Burlo Garofolo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
1 Years to 17 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Number of participants with peripheral intravenous catheter patencyUntil catheter use (i.e. drug infusion) or removal (catether related complication or no further need of use), with an expected avarage of 48 hoursPatency 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

MeasureTime frameDescription
Number of participants with painUntil catheter use (i.e. drug infusion) or removal (catether related complication or no further need of use), with an expected avarage of 48 hoursAny pain at the site of catheter insertion referred by patients to nurses
Number of participants with blood extravasationUntil catheter use (i.e. drug infusion) or removal (catether related complication or no further need of use), with an expected avarage of 48 hoursPresence 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 skin rednessUntil catheter use (i.e. drug infusion) or removal (catether related complication or no further need of use), with an expected avarage of 48 hoursPresence of skin redness at the site of catheter insertion at the time of nurse's evaluation
Number of participants with swellingUntil catheter use (i.e. drug infusion) or removal (catether related complication or no further need of use), with an expected avarage of 48 hoursPresence of swelling in the site of catheter insertion at the time of nurse's evaluation

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026