Randomised controlled trial of an integrated securement device or tissue adhesive versus standard care (bordered polyurethane) dressings on peripheral intravenous cannula failure in paediatric patients.

Not Applicable

Recruiting

Conditions: Peripheral IntraVenous Cannula failure prior to completion of therapy
Public Health - Health service research
Emergency medicine - Other emergency care

Registration Number: ACTRN12619001026112

Lead Sponsor: Griffith University

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 506

Inclusion Criteria

•Aged greater than 6 months to 8 years inclusive
•Anticipated requirement for a PIVC for more than 24hours
•Hospital admission to the inpatient unit requiring an expected stay of 24 hours or more

Exclusion Criteria

•Known allergy to study products
•Non-English-speaking family without interpreters
•Has a currently identified blood stream infection
•Current skin tear or at high risk of tear
•Previous participation in the study

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary aim of this study is to test PIVC failure: composite of any unplanned PIVC removal, where reinsertion is required. This includes complete dislodgement, infection, occlusion (PIVC cannot be flushed, or leakage occurs when fluid infused), infiltration (fluid perfusion into the surrounding tissue), phlebitis (2 or more of pain, redness, swelling). A composite measure, that will increase trial precision and efficiency, was chosen since PIVC failure is the outcome of importance to patients, with poor securement leading to the same endpoint. This will be measured through iEMR records, FLACC and FACES pain tool and documented nursing observations. [On removal of the PIVC as decided by the treating doctor as no longer required for up to 4 weeks or at the time of loss of PIVC from complications such as accidental removal or occlusion (as appropriate).]

Secondary Outcome Measures