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

IRCCS Burlo Garofolo

Status and phase: Completed; Phase 3

Conditions: Pain

Treatments: Device: MicroClave ICU Medica; Drug: Normal saline; Procedure: Flushing with positive pressure

Study type: Interventional

Funder types: Other

Identifiers

NCT02221024

RC 10/11

Details and patient eligibility

About

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.

Enrollment: 400 patients

Sex: All

Ages: 1 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 2 patient groups

Flushing every 24 hours

Experimental group

Description:

Flushing with positive pressure with normal saline every 24 hours

Treatment:

Device: MicroClave ICU Medica

Drug: Normal saline

Procedure: Flushing with positive pressure

Flushing every 12 hours

Active Comparator group

Description:

Flushing with positive pressure with normal saline every 12 hours

Treatment:

Device: MicroClave ICU Medica

Drug: Normal saline

Procedure: Flushing with positive pressure