Radiological issues in spinal immobilization

ISRCTN	ISRCTN68626238
DOI	https://doi.org/10.1186/ISRCTN68626238
Secondary identifying numbers	METC 13-4-113

Submission date: 16/07/2015
Registration date: 18/08/2015
Last edited: 04/08/2015

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

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

Contact information

Miss Baukje Hemmes
Scientific

Bogaartsborg 3
Maastricht
6228AK
Netherlands

Study information

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
Study setting(s)	Hospital
Study type	Other
Participant information sheet	Not available in web format, please use contact details to request a participant information sheet
Scientific title	Radiation exposure and objective and subjective image quality in spinal immobilization: a comparison of patient data and phantom data
Study objectives	Devices for spinal immobilization decrease image quality and increase radiation exposure
Ethics approval(s)	METC MUMC (Medical Ethics Committee of the Maastricht University Medical Center), 19/12/2013, ref: METC 13-4-113
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase
Drug / device / biological / vaccine name(s)
Primary outcome measure	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 study start date	01/10/2013
Completion date	01/06/2015

Eligibility

Participant type(s)	Mixed
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	N/A
Key inclusion criteria	Patients who underwent CT of the head in 2011 while on a device for spinal immobilization, aged 18 or older
Key exclusion criteria	Patients are excluded when the type of device(s) used are unknown
Date of first enrolment	01/01/2014
Date of final enrolment	01/03/2014

Locations

Countries of recruitment

Netherlands
Netherlands Antilles

Study participating centre

Maastricht University Medical Center

Maastricht
6202AZ
Netherlands

Sponsor information

Maastricht University Medical Center
Hospital/treatment centre

P. Debyelaan 25
Maastricht
6229HX
Netherlands

"ROR"	https://ror.org/02d9ce178

Funders

Funder type

Hospital/treatment centre

Maastricht University Medical Center (Netherlands)

No information available

Results and Publications

Intention to publish date	01/09/2015
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Stored in repository
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.
IPD sharing plan