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Secure My Intravascular Line Effectively (SMILE): a pilot randomised controlled trial to improve the dressing and securement of arterial catheters in an adult intensive care population.

Factorial, superiority, pilot randomised controlled trial testing alternative (1) dressing (chlorhexidine impregnated disc) and (2) securement (integrated securement device) to prevent arterial catheter failure and catheter associated bloodstream infection in an adult intensive care population.

Status
Withdrawn
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12616000985482
Acronym
The SMILE Trial
Enrollment
120
Registered
2016-07-27
Start date
2016-08-01
Completion date
2017-03-01
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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 (IAL). 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 four IAL dressing/securement options. These will be either (i) the standard simple polyurethane dressing; (ii) the standard simple polyurethane dressing and a chlorhexidine impregnated disc; (iii) an integrated securement device and simple polyurethane dressing combined into a single device; (iv) or an integrated securement device and chlorhexidine impregnated disc. 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, device failures and infections. It is hoped that the findings of this trial will provide information on which IAL securements and dressings are most effective in preventing IAL failure.

Interventions

Participants in this study will have intra-arterial catheters (IAL) used in adult intensive care departments. Consenting patients will have their IAL dressed and secured with one of the following randomly assigned options: Arm 1 (Control): Simple polyurethane dressing (SP). Arm 2: Securement device; simple polyurethane dressing and a chlorhexidine impregnated (CHG) disc. Arm 3: Integrated securement device. Integrated securement devices (ISDs) are simple polyurethane dressings which combine b

Participants in this study will have intra-arterial catheters (IAL) used in adult intensive care departments. Consenting patients will have their IAL dressed and secured with one of the following randomly assigned options: Arm 1 (Control): Simple polyurethane dressing (SP). Arm 2: Securement device; simple polyurethane dressing and a chlorhexidine impregnated (CHG) disc. Arm 3: Integrated securement device. Integrated securement devices (ISDs) are simple polyurethane dressings which combine both dressing and securement properties into one product. Arm 4: Integrated securement device and a chlorhexidine impregnated disc. 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
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Factorial
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. IAL in situ 3. IAL scheduled/expected use >24 hours 4. Patient aged 16 years or above 5, Patients admitted (or being admitted to) the Intensive Care Unit

Exclusion criteria

1. Known, current bloodstream infection (within 48 hours) 2. Non-English speakers without interpreter 3. IALs inserted through diseased, burned or scarred skin 4. Other types of vascular access devices 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

Source: ANZCTR · Data processed: Feb 4, 2026