Plain English Summary
Background and study aim
A central venous catheter (CVC) is a device inserted into a large vein for drug and fluid administration, cardiovascular (heart) monitoring and kidney support. It is commonly used in critically ill patients or those having major surgery. A CVC can be inserted in the neck (internal jugular), close to the chest (subclavian) or in groin veins (femoral). When inserted in the internal jugular or subclavian veins, a chest x-ray is usually performed afterwards to confirm the catheter is in the correct position and check for injury to the lung (pneumothorax). In the past CVC placement was done as a blind procedure based on anatomical landmarks. In 2002 the National Institute for Health and Clinical Excellence (NICE) recommended the use of ultrasound to guide CVC insertion. The use of ultrasound has improved the success rate and reduced the complications previously associated with CVC insertion. This study addresses the question of whether ultrasound can serve as a diagnostic tool following CVC insertion instead of a chest x-ray.
Who can participate?
Adult patients in whom the attending Intensivist or Anaesthetist decides to insert a CVC and for which a chest x-ray would normally be performed.
What does the study involve?
The decision to insert a CVC is based on the clinical judgement of the attending Intensivist or Anaesthetist. After CVC insertion a member of the research team is contacted to perform the ultrasound examination. The standard series of ultrasound images is checked to confirm the correct CVC position, and identify catheter misplacement or punctured lung (pneumothorax). The ability to record these standard ultrasound images, the quality of the images and the image findings are recorded by the researcher. All patients subsequently have a chest x-ray as is the normal practice after CVC insertion. The accuracy of information provided by the ultrasound is compared to that from the chest x-ray.
What are the possible benefits and risks of participating?
All patients will have a chest x-ray, which is the normal check, in addition to an ultrasound examination. This should increase the chance of diagnosing any complications. The ultrasound examination is non-invasive and does not cause pain or discomfort.
Where is the study run from?
The Royal Sussex County Hospital (UK)
When is the study starting and how long is it expected to run for?
June 2012 to May 2013
Who is funding the study?
The Royal Sussex County Hospital (UK)
Who is the main contact?
Dr J.A. Ezihe-Ejiofor
adaezihe@doctors.org.uk
Trial website
Contact information
Type
Scientific
Primary contact
Dr J. Adanma Ezihe-Ejiofor
ORCID ID
Contact details
The Royal Sussex County Hospital
Department of Anaesthetics
Brighton
BN2 5BE
United Kingdom
+44 (0)1273 696 955
adaezihe@doctors.org.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
CVC-01
Study information
Scientific title
Can ultrasound examination safely replace chest radiography after central venous catheter insertion? A feasibility study
Acronym
Study hypothesis
An ultrasound examination can produce images of sufficient diagnostic quality to enable it serve as a post procedure check instead of chest x-ray after central venous catheter insertion. This will obviate the need for routine chest x-ray, avoid unnecessary patient exposure to radiation and minimize delays in starting therapy while waiting for radiography.
Ethics approval
Not provided at time of registration
Study design
Prospective cross-over trial
Primary study design
Interventional
Secondary study design
Randomised cross over trial
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Central venous catheter insertion and ultrasound examination
Intervention
All patients will have an ultrasound examination of the heart and chest post CVC insertion.
Intervention type
Procedure/Surgery
Phase
Not Applicable
Drug names
Primary outcome measure
1. Successful use of the ultrasound examination to generate images of sufficient diagnostic quality to facilitate a post CVC insertion check.
2. Successful use of the images generated in (a) to enable the operator:
2.1. Identify correct CVC tip position
2.2. Exclude CVC misplacement
2.3. Exclude a pneumothorax
Secondary outcome measures
1. The time taken to complete the ultrasound examination
2. The time taken from contacting the radiology department to the chest radiograph becoming available to view on the Picture Archiving and Communication System (PACS)
Overall trial start date
01/06/2012
Overall trial end date
01/05/2013
Reason abandoned (if study stopped)
Lack of staff/facilities/resources
Eligibility
Participant inclusion criteria
Adult patients in whom the attending clinician plans to insert a central venous catheter (CVC) into the internal jugular or subclavian vein and for which a routine post procedural chest x-ray would normally be done.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
200
Participant exclusion criteria
1. Patients less than 16 years old
2. Adult patients in whom the attending clinician plans to insert a central venous catheter (CVC) into the groin (femoral) vein as a chest x-ray is not normally done for this insertion route
3. Patients who refuse to give consent for the ultrasound examination
Recruitment start date
01/06/2012
Recruitment end date
01/05/2013
Locations
Countries of recruitment
United Kingdom
Trial participating centre
The Royal Sussex County Hospital
Brighton
BN2 5BE
United Kingdom
Sponsor information
Organisation
Brighton and Sussex University Hospitals NHS Trust (UK)
Sponsor details
The Royal Sussex County Hospital
Eastern Road
Brighton
BN2 5BE
United Kingdom
+44 (0)1273 696 955
Scott.Harfield@bsuh.nhs.uk
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Royal Sussex County Hospital (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list