Clinical trial NCT02221024: Normal Saline Flushes at 12 vs 24 Hours Intervals for Maintaining Peripheral Intravenous Catheters Patency
Official title: Randomized Controlled Trial to Evaluate the Efficacy of Normal Saline Flushes at 12 and 24 Hours Intervals in Maintaining Peripheral Intravenous Catheters Patency
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain
Keywords: Peripheral intravenous catheter
Peripheral intravenous lock
Normal saline
Patency
Management
of peripheral
intravenous catheter
Lead sponsor: IRCCS Burlo Garofolo
Sponsor class: OTHER
First posted: 2014-08-20
Enrollment: 400
Sex: ALL
Minimum age (years): 1
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of participants with peripheral intravenous catheter patency
timeFrame: 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:
measure: Number of participants with blood extravasation
timeFrame: 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
measure: Number of participants with pain
timeFrame: 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
measure: Number of participants with skin redness
timeFrame: 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
measure: Number of participants with swelling
timeFrame: 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
Other outcomes:
Locations:
city: Trieste
country: Italy
facility: Emergency Department, IRCCS Burlo Garofolo
state: Friuli Venezia Giulia
Study officials:
affiliation: IRCCS Burlo Garofolo, Trieste, Italy
name: Egidio Barbi, MD
role: STUDY_CHAIR
affiliation: IRCCS Burlo Garofolo, Trieste, Italy
name: Silvana Schreiber, RN
role: STUDY_DIRECTOR
References:
citation: 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.