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A clinical evaluation of a CVC securement device

A clinical evaluation of two central venous catheter stabilization systems

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN13939744
Enrollment
168
Registered
2015-07-09
Start date
2015-09-08
Completion date
Unknown
Last updated
2019-05-13

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

Conditions

Topic: Critical care

Interventions

CVC securement: a short-term central venous catheter is secured onto the skin using either sutures and a transparent dressing, or a sutureless securement system which consists of a molded plastic devi

Sponsors

University Hospitals Birmingham NHS Foundation Trust
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. =18 years of age 2. Admitted, or to be admitted, to a critical care unit 3. Require a single, short-term, non-cuffed, non-tunnelled CVC (up to and including 12F in size) as part of their clinical care 4. Willing and able to provide written informed consent (or if their condition do not allow this their legally authorized representative willing and able to give the consent on their behalf)

Exclusion criteria

Exclusion criteria: 1. Confused (patients who have a positive CAMICU score or if confusion expected after sedation stopped) 2. Excessively perspiring (skin becomes moist within 2 minutes of drying) 3. Non adherent skin burn, trauma or other condition affecting the skin integrity in close proximity to the potential insertion site, so that the device/ suture is applied to the skin without any of these conditions 4. Underlying uncorrected bleeding diathesis 5. Known allergy to adhesives or device components 6. To have more than one catheter inserted at the same location 7. Pregnant or breastfeeding women 8. Past participants in this study

Design outcomes

Primary

MeasureTime frame
Total number of catheter dislodgements. Recorded daily (for the duration of CVC placement) using standard clinical observation methods.

Secondary

MeasureTime frame
1. Number of complete catheter dislodgements (i.e. number of unplanned catheter removals) 2. Number of partial catheter dislodgement: (i.e. catheter migration at the skin insertion site but not resulting in unplanned catheter removal; measured in mm) 3. Securement device adherence onto skin and catheter (full or partial) 4. Number of catheters requiring immediate repositioning of securement device 5. Number of dressing changes per catheter 6. Number of reported unresolved occlusions of the catheter 7. Catheter insertion site visible on routine clinical inspection (yes or no) 8. Number of patients requiring an alternative catheter securement method to which the subject was originally selected 9. Reasons for requiring an alternative catheter securement method to which the subject was originally selected 10. Clinical staff satisfaction (questionnaire) 11. Patient comfort level: subjective (pain score if able to communicate) and objective evaluation (skin condition) on application and removal of the securement device Recorded daily (for the duration of CVC placement) using standard clinical observation methods

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 3, 2026