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

Study Overview
=================
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.

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

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Procedure: Flushing with positive pressure
* Drug: Normal saline
* Device: MicroClave ICU Medica


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 17 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Flushing every 24 hours<br>Flushing with positive pressure with normal saline every 24 hours | Procedure: Flushing with positive pressure<br>* 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)<br>Drug: Normal saline<br> <br> * Other names: Physiological saline solution;Device: MicroClave ICU Medica<br> <br> |
| Active Comparator: Flushing every 12 hours<br>Flushing with positive pressure with normal saline every 12 hours | Procedure: Flushing with positive pressure<br>* 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)<br>Drug: Normal saline<br> <br> * Other names: Physiological saline solution;Device: MicroClave ICU Medica<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with peripheral intravenous catheter patency | 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 | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with blood extravasation | 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 | 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 | 
| Number of participants with pain | Any pain at the site of catheter insertion referred by patients to nurses | 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 | 
| Number of participants with skin redness | Presence of skin redness at the site of catheter insertion at the time of nurse's evaluation | 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 | 
| Number of participants with swelling | Presence of swelling in the site of catheter insertion at the time of nurse's evaluation | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Peripheral intravenous catheter, Peripheral intravenous lock, Normal saline, Patency, Management, of peripheral, intravenous catheter