Condition category
Surgery
Date applied
20/05/2012
Date assigned
07/06/2012
Last edited
01/03/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 measures

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

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

http://www.bsuh.nhs.uk/

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

01/03/2016: No publications found, verifying study status with principal investigator