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, inflammation, occlusion, infiltration/extravasation, dislodgement and/or poor trace; (ii) compare usual care dressings with two novel methods; (iii) evaluate the acceptability of these devices to patients and health professionals; and (iv) study adverse effect profiles. You or your child may be eligible to participate in this trial if you are an intensive care patient under the age of 18 and are having an intra-arterial catheter inserted as part of your required 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 three IAC securement options. This will be either the standard bordered polyurethane dressing; medical grade superglue, or an integrated securement device. The allocated dressing will be applied from device insertion until the time of device removal. Participants and families 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 among paediatric patients.
Interventions
Participants in this study will have intra-arterial catheters (IAC) inserted in paediatric intensive care departments and operating theatres. Consenting patients will have their IAC dressed and secured with one of the three following randomly assigned options:
Arm 1 (Control): Bordered polyurethane dressing (BPU), with foam applied as per hospital policy.
Arm 2 (Intervention): Integrated securement device, with a sterile foam cushioning applied. Integrated securement devices (ISDs) are simple
Participants in this study will have intra-arterial catheters (IAC) inserted in paediatric intensive care departments and operating theatres. Consenting patients will have their IAC dressed and secured with one of the three following randomly assigned options: Arm 1 (Control): Bordered polyurethane dressing (BPU), with foam applied as per hospital policy. Arm 2 (Intervention): Integrated securement device, with a sterile foam cushioning applied. Integrated securement devices (ISDs) are simple polyurethane dressings which combine both dressing and securement properties into one product. Arm 3 (Intervention): Tissue Adhesive (TA). TA is a medical grade 'superglue' (cyanoacrylate) used mainly to close skin lacerations/wounds as an alternative to sutures and staples. A bordered polyurethane dressing (with foam) will also applied as per hospital policy. Patients will be monitored daily to ensure protocol adherence and assess for any complications. 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
No minimum to 18 Years
Healthy volunteers
No
Inclusion criteria
1. Informed written consent 2. IAC to be inserted 3. IAC scheduled/expected use >24 hours 4. Patient aged 18 years or below 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