Securing Arterial and Venous devices Effectively in hospitals (The SAVE trial)

Not Applicable

Completed

• Conditions: Intravenous and arterial device failure prior to completion of therapy; Public Health - Health service research

• Registration Number: ACTRN12611000769987
• Lead Sponsor: Griffith University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-07-22
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 2128

Inclusion Criteria

1. Informed written consent
2. Intravenous or arterial IVD in situ.
3. IVD scheduled/expected use > 24 hours

Exclusion Criteria

1.Non-English speaking patients without interpreter
2.IVD inserted through burned or diseased skin
3.Extremely diaphoretic patients
4.Known allergy to any study product

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
IVD failure. <br><br>Composite of any unplanned IVD removal, prior to completion of therapy. This includes dislodgement (complete), occlusion (IVD will not infuse, or leakage occurs when fluid infused), phlebitis (2 or more of pain, redness, swelling and a palpable cord), and infection (laboratory confirmed local or bloodstream infection). A composite measure was chosen since IVD failure is the outcome of importance to patients, with poor securement taking various pathways to the same endpoint.<br><br>The primary outcome of device failure is an objective measure, assigned by clinical staff (not research staff or investigators). This is routine clinical practice. Research staff will collect the primary endpoint from the medical records with additional information obtained from the clinical staff/patients if required.[At the time of IVD removal.]