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

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ClinicalTrials.gov Identifier: NCT02221024
Recruitment Status : Completed
First Posted : August 20, 2014
Last Update Posted : August 20, 2014
Sponsor:
Information provided by (Responsible Party):
Ronfani Luca, 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.


Condition or disease Intervention/treatment Phase
Pain Procedure: Flushing with positive pressure Drug: Normal saline Device: MicroClave ICU Medica Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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 Start Date : July 2011
Actual Primary Completion Date : September 2013
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Flushing every 24 hours
Flushing with positive pressure with normal saline every 24 hours
Procedure: Flushing 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)

Drug: Normal saline
Other Names:
  • Isotonic saline solution
  • Physiological saline solution

Device: MicroClave ICU Medica
Active Comparator: Flushing every 12 hours
Flushing with positive pressure with normal saline every 12 hours
Procedure: Flushing 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)

Drug: Normal saline
Other Names:
  • Isotonic saline solution
  • Physiological saline solution

Device: MicroClave ICU Medica



Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   1 Year to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02221024


Locations
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Italy
Emergency Department, IRCCS Burlo Garofolo
Trieste, Friuli Venezia Giulia, Italy, 34137
Sponsors and Collaborators
IRCCS Burlo Garofolo
Investigators
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Study Chair: Egidio Barbi, MD IRCCS Burlo Garofolo, Trieste, Italy
Study Director: Silvana Schreiber, RN IRCCS Burlo Garofolo, Trieste, Italy
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ronfani Luca, MD, PhD, IRCCS Burlo Garofolo
ClinicalTrials.gov Identifier: NCT02221024    
Other Study ID Numbers: RC 10/11
First Posted: August 20, 2014    Key Record Dates
Last Update Posted: August 20, 2014
Last Verified: August 2014
Keywords provided by Ronfani Luca, IRCCS Burlo Garofolo:
Peripheral intravenous catheter
Peripheral intravenous lock
Normal saline
Patency
Management
of peripheral
intravenous catheter
Additional relevant MeSH terms:
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Pharmaceutical Solutions