Plain English Summary
Background and study aims
Central venous catheters (CVC) are inserted into many patients for the administration of treatment and haemodynamic monitoring (for measuring blood pressure and oxygen levels in the blood) . Sutures (stitches) are frequently used to secure CVC onto the skin, however application of sutures carries a risk of needle stick injury to the clinician, discomfort to the patient and trauma at the CVC insertion site. Moreover, the sutures securing CVC are often highly colonized with bacteria despite scrupulous CVC site care, and may serve as a source for an infection. CVC movement may introduce microorganisms from the skin surface along the CVC and contribute to an infection. Therefore alternative securement methods for short term CVC needs to be tested. Alternative CVC securement methods are available, such as adhesive devices/tapes/dressings; however these have been used for securing CVC that are placed through veins in the arm. Knowledge of securement device for CVC, which are inserted into neck, chest or groin, is limited. This study will test the safety of the device, whether what is being measured is appropriate and measurable and whether the device is acceptable to clinical users.
Who can participate?
Adults (18 or over) being treated, or about to be treated, in a critical care unit and needing a CVC.
What does the study involve?
Participants are randomly allocated into one of two groups. Those in group 1 have sutures securing their CVC. Those in group 2 have the CVC securement device applied to secure the CVC. The patients are observed for any CVC related complications and CVC placement is measured daily. Comfort of the patient and user acceptability is evaluated where appropriate.
What are the possible benefits and risks of participating?
Participants may not have any direct medical benefit from being in this study; however the information gained from this study will help improve the treatment of future patients who have a catheter inserted as part of their medical care. Catheter stabilization is recognised as an intervention to decrease the risk for phlebitis and catheter displacement, and may be advantageous in preventing catheter related bloodstream infections. Risks include skin irritation and damage to the skin, improper use of the catheter securement system or displacement of it, infection and air embolism.
Where is the study run from?
University Hospitals Birmingham NHS Foundation Trust (UK).
When is the study starting and how long is it expected to run for?
June 2014 to June 2017
Who is funding the study?
3M Deutschland GmbH
Who is the main contact?
Dr Tarja Karpanen
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
18974
Study information
Scientific title
A clinical evaluation of two central venous catheter stabilization systems
Acronym
Study hypothesis
The aim of this feasibility study is to assess the safety of a new securement device for central venous catheters (CVC), to see whether the proposed study parameters are appropriate and measurable, and the securement device is acceptable to clinical users.
Ethics approval
NRES Committee North West – Greater Manchester South, 27/04/2015, ref: 15/NW/0185
Study design
Randomised; Interventional; Design type: Treatment
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Topic: Critical care; Subtopic: Critical care; Disease: All Critical care
Intervention
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 device with an adhesive backing and a transparent film dressing.
Intervention type
Device
Phase
Drug names
Primary outcome measure
Total number of catheter dislodgements. Recorded daily (for the duration of CVC placement) using standard clinical observation methods.
Secondary outcome measures
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
Overall trial start date
18/06/2014
Overall trial end date
14/06/2017
Reason abandoned (if study stopped)
Eligibility
Participant 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)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 168; UK Sample Size: 42
Participant 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
Recruitment start date
08/09/2015
Recruitment end date
31/01/2017
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University Hospitals Birmingham NHS Foundation Trust
Birmingham
B15 2GW
United Kingdom
Trial participating centre
Bichat-Claude Bernard Hopital
Paris
75018
France
Trial participating centre
University Hospital (Centre Hospitalier Universitaire), Universite de Poitiers et Inserm
Poitiers
86021
France
Trial participating centre
University Hospital Arnau de Vilanova (University Hospital Arnau de Vilanova)
Lleida
25198
Spain
Funders
Funder type
Industry
Funder name
3M Deutschland GmbH
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
This is a feasibility study. The results may be published in a scientific journal or presented at a scientific meeting.
IPD sharing statement:
The datasets are not made publicly available as consent from patients were not sought for data to be used for other research/sent outside of EU
Intention to publish date
14/06/2018
Participant level data
Not expected to be available
Basic results (scientific)
See additional file (ISRCTN13939744_BasicResults_06Sep2018.pdf)
Publication list
Publication citations
Additional files
- ISRCTN13939744_BasicResults_06Sep2018.pdf Uploaded 06/09/2018