Ultrasound versus chest radiography after central venous catheter insertion

ISRCTN	ISRCTN94127149
DOI	https://doi.org/10.1186/ISRCTN94127149
Secondary identifying numbers	CVC-01

Submission date: 20/05/2012
Registration date: 07/06/2012
Last edited: 15/05/2018

Recruitment status: No longer recruiting
Overall study status: Stopped
Condition category: Surgery

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

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

Contact information

Dr J. Adanma Ezihe-Ejiofor
Scientific

The Royal Sussex County Hospital
Department of Anaesthetics
Brighton
BN2 5BE
United Kingdom

Phone	+44 (0)1273 696 955
Email	adaezihe@doctors.org.uk

Study information

Study design	Prospective cross-over trial
Primary study design	Interventional
Secondary study design	Randomised cross over trial
Study setting(s)	Hospital
Study type	Diagnostic
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Can ultrasound examination safely replace chest radiography after central venous catheter insertion? A feasibility study
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
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 study start date	01/06/2012
Completion date	01/05/2013
Reason abandoned (if study stopped)	Lack of staff/facilities/resources

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	200
Key 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.
Key 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
Date of first enrolment	01/06/2012
Date of final enrolment	01/05/2013

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

The Royal Sussex County Hospital

Brighton
BN2 5BE
United Kingdom

Sponsor information

Brighton and Sussex University Hospitals NHS Trust (UK)
Hospital/treatment centre

The Royal Sussex County Hospital
Eastern Road
Brighton
BN2 5BE
England
United Kingdom

Phone	+44 (0)1273 696 955
Email	Scott.Harfield@bsuh.nhs.uk
Website	http://www.bsuh.nhs.uk/

Funders

Funder type

Hospital/treatment centre

Royal Sussex County Hospital (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

15/05/2018: Principal investigator has confirmed that trial was stopped early and no publication of results is expected.
11/05/2018: No publications found, verifying study status with principal investigator
01/03/2016: No publications found, verifying study status with principal investigator