Plain English Summary
Background and study aims
Patients who have been in an accident and are suspected of spinal injury are routinely treated with devices for spinal immobilization in order to stabilise the spinal column after injury and therefore prevent injury to the spinal cord. These devices are usually left in place while the patient is in the Emergency Room for assessment, including taking x-rays or making CT scans. However, the presence of these devices may hamper judgement of these images since they can produce artefacts (e.g. lines). Also, the presence of the devices may increase the amount of radiation the patient is exposed to. CT scanners and x-ray machines automatically adjust the radiation dose for imaging to get consistent image quality, and increase the dose when there is more matter (be it patient of device) to beam through. With this study we judge patient CT scans to assess image quality, and we measure radiation exposure using a phantom. We want to know which device therefore produces the best image quality and the least radiation exposure
Who can participate?
Adults (aged at least 18) than had a CT scan of their head while on a device for spinal immobilization in 2011.
What does the study involve?
Patients CT scans are assessed retrospectively for the presence and extent of artifacts caused by the spinal immobilization device used. Phantom CT scans and x-rays are assessed prospectively for radiation exposure in relation to the spinal immobilization device being used.
What are the possible benefits and risks of participating?
There are no benefits or risks to participants.
Where is the study run from?
Maastricht University Medical Center (Netherlands)
When is the study starting and how long is it expected to run for?
August 2013 to December 2014
Who is funding the study?
Maastricht University Medical Center (Netherlands)
Who is the main contact?
Miss Baukje Hemmes
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
METC 13-4-113
Study information
Scientific title
Radiation exposure and objective and subjective image quality in spinal immobilization: a comparison of patient data and phantom data
Acronym
Study hypothesis
Devices for spinal immobilization decrease image quality and increase radiation exposure
Ethics approval
METC MUMC (Medical Ethics Committee of the Maastricht University Medical Center), 19/12/2013, ref: METC 13-4-113
Study design
1. Retrospective evaluation of CT scans of patients
2. Prospective evaluation of CT scans and x-rays of a phantom
3. Single center study
Primary study design
Observational
Secondary study design
Trial setting
Hospitals
Trial type
Other
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Radiation exposure and radiological image quality
Intervention
1. Patients CT scans are assessed retrospectively for the presence and extent of artifacts in relation to spinal immobilization device used.
2. Phantom CT scans and x-rays are assessed prospectively for radiation exposure in relation to spinal immobilization device used.
Intervention type
Device
Phase
Drug names
Primary outcome measures
1. Artifacts are scored independently by two trained judges, based on presence and impact of any disturbance of the image, which can be related back to the spinal immobilization device
2. Radiation exposure is measured using an ionisation chamber and electrometer
3. Noise is measured in SD of the CT values (in Hounsfield Units) of the pixels within 16 circular regions of interest covering 51% of the phantom using ImageJ
Secondary outcome measures
Overall assessment of the question which device for spinal immobilization performs best from a radiological point of view, with recommendations for clinical use.
Overall trial start date
01/10/2013
Overall trial end date
01/06/2015
Reason abandoned
Eligibility
Participant inclusion criteria
Patients who underwent CT of the head in 2011 while on a device for spinal immobilization, aged 18 or older
Participant type
Mixed
Age group
Adult
Gender
Both
Target number of participants
N/A
Participant exclusion criteria
Patients are excluded when the type of device(s) used are unknown
Recruitment start date
01/01/2014
Recruitment end date
01/03/2014
Locations
Countries of recruitment
Netherlands Antilles
Trial participating centre
Maastricht University Medical Center
Maastricht
6202AZ
Netherlands
Funders
Funder type
Hospital/treatment centre
Funder name
Maastricht University Medical Center (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Results of the study will be offered for publication in peer reviewed international journals and for presentation at a national congress (Traumadagen [Dutch national trauma days]). We intend to offer the manuscript for publication as soon as ISRCTN registration is completed. We intend to give a presentation at the Traumadagen 2016.
Intention to publish date
01/09/2015
Participant level data
Stored in repository
Results - basic reporting
Publication summary