None listed
Conditions
Brief summary
The primary aim of this study is to pilot test the feasibility of a randomised trial that compares the effectiveness of new generation securement and dressing products for intra-arterial catheters (IAC). The RCT aims to (i) identify clinical, cost-effective methods to prevent catheter failure due to infection, phlebitis, occlusion, and dislodgement; (ii) compare usual care dressings with a novel method; (iii) evaluate the acceptability of these devices to patients and health professionals; and (iv) study adverse effect profiles. You may be eligible to participate in this trial if you are an intensive care patient over the age of 16 and are having an intra-arterial catheter inserted as part of your therapy (which is expected to remain in place for at least 24 hours). All participants enrolled in this trial will be randomly allocated (by chance) to receive one of two IAC securement options. These will be either (i) the standard simple polyurethane dressing; or (ii) an integrated securement device and simple polyurethane dressing combined into a single device The allocated dressing will be applied from device insertion until the time of device removal. Participants will be asked to rate the acceptability of the device and dressing, and the device will be observed closely to examine side effects, and device failures. It is hoped that the findings of this trial will provide information on which IAC securements are most effective in preventing IAC failure.
Interventions
Participants in this study will have intra-arterial catheters (IAC) inserted in adult intensive care departments. Consenting patients will have their IAC dressed and secured with one of the two following randomly assigned options:
Arm 1 (Control): Simple polyurethane dressing (SP), with gauze/foam applied as per hospital policy
Arm 2: Integrated securement device. Integrated securement devices (ISDs) are simple polyurethane dressings which combine both dressing and securement properties into o
Participants in this study will have intra-arterial catheters (IAC) inserted in adult intensive care departments. Consenting patients will have their IAC dressed and secured with one of the two following randomly assigned options: Arm 1 (Control): Simple polyurethane dressing (SP), with gauze/foam applied as per hospital policy Arm 2: Integrated securement device. Integrated securement devices (ISDs) are simple polyurethane dressings which combine both dressing and securement properties into one product. Patients will be monitored daily to ensure protocol adherence. The randomly allocated dressing will be applied from device insertion and changed as clinically indicated until removal of device.
Sponsors
Griffith University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Informed written consent 2. IAC to be inserted 3. IAC scheduled/expected use >24 hours 4. Patient aged 16 years or above 5, Patients admitted to the Intensive Care Unit
Exclusion criteria
1. Known, current bloodstream infection (within 48 hours) 2. Non-English speakers without interpreter 3. IACs inserted through diseased, burned or scarred skin 4, IACs inserted into the femoral artery 5. Current skin tear/‘papery’ skin at high risk of tear 6. Known allergy to any study product 7. Previous enrolment in the current study
Outcome results
None listed