A clinical evaluation of a CVC securement device

Not Applicable

Completed

• Conditions: Topic: Critical care; Subtopic: Critical care; Disease: All Critical care; Signs and Symptoms

• Registration Number: ISRCTN13939744
• Lead Sponsor: niversity Hospitals Birmingham NHS Foundation Trust

Brief Summary

2019 results in https://www.ncbi.nlm.nih.gov/pubmed/30997586 (added 23/04/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-07-09
• Study Completion: 2017-06-14
• Last Update Posted: 13 May 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 186

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified