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

NCT ID: NCT02221024

Last Updated: 2014-08-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2013-09-30

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.

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Flushing every 24 hours

Flushing with positive pressure with normal saline every 24 hours

Group Type: EXPERIMENTAL

Flushing with positive pressure

Intervention Type: 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

Intervention Type: DRUG

MicroClave ICU Medica

Intervention Type: DEVICE

Flushing every 12 hours

Flushing with positive pressure with normal saline every 12 hours

Group Type: ACTIVE_COMPARATOR

Flushing with positive pressure

Intervention Type: 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

Intervention Type: DRUG

MicroClave ICU Medica

Intervention Type: DEVICE

Interventions

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)

Intervention Type: PROCEDURE

Normal saline

Intervention Type: DRUG

MicroClave ICU Medica

Intervention Type: DEVICE

Other Intervention Names

Isotonic saline solution; Physiological saline solution

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

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IRCCS Burlo Garofolo

OTHER

Sponsor Role: lead

Responsible Party

Ronfani Luca

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Egidio Barbi, MD

Role: STUDY_CHAIR

IRCCS Burlo Garofolo, Trieste, Italy

Silvana Schreiber, RN

Role: STUDY_DIRECTOR

IRCCS Burlo Garofolo, Trieste, Italy

Locations

Emergency Department, IRCCS Burlo Garofolo

Trieste, Friuli Venezia Giulia, Italy

Countries

Italy

References

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.

Reference Type: DERIVED

PMID: 25589559 (View on PubMed)

Other Identifiers

RC 10/11

Identifier Type: -

Identifier Source: org_study_id