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Completed

NCT Number: NCT02221024

Normal Saline Flushes at 12 vs 24 Hours Intervals for 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.

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Key information

Conditions

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

Age range

1 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Emergency Department, IRCCS Burlo Garofolo

Trieste, Friuli Venezia Giulia, 34137, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

normal saline

Drug

Other names: Isotonic saline solution, Physiological saline solution

MicroClave ICU Medica

Device

Primary outcomes

  1. Number of participants with peripheral intravenous catheter patency

    Time frame: 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 outcomes

  1. Number of participants with blood extravasation

    Time frame: 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

  2. Number of participants with pain

    Time frame: 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

  3. Number of participants with skin redness

    Time frame: 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

  4. Number of participants with swelling

    Time frame: 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

Sponsors and collaborators

Lead sponsor

IRCCS Burlo Garofolo

Other

Registry information

Official study title

Randomized Controlled Trial to Evaluate the Efficacy of Normal Saline Flushes at 12 and 24 Hours Intervals in Maintaining Peripheral Intravenous Catheters Patency

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Aug 20, 2014
Registry last updated
Aug 20, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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