Contact information
Type
Scientific
Primary contact
Dr Rose Jarvis
ORCID ID
Contact details
University of Warwick
Gibbet Hill Road
Coventry
CV4 7AL
United Kingdom
-
rose.jarvis@warwick.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
12376
Study information
Scientific title
Warwick Spinal Immobiliser - development and initial trial of prototype spinal immobilisation device
Acronym
Study hypothesis
Traumatic spinal cord injury (SCI) is rare but has devastating consequences on the quality of life of patients and their families. Figures from the UK are difficult to obtain, but we estimate that 100,000 patients in England receive spinal immobilisation each year. As modern trauma care appropriately assumes that injury is present until excluded, this creates a huge demand for effective spinal immobilisation.
Current methods usually involve a semi-rigid collar with head blocks and tape, but we and others have shown that this does not adequately immobilise the neck, allowing movement of the spine risking further injury. The rigid collar prevents opening of the mouth leading to feelings of claustrophobia, and potential danger of inhaling vomit. If the patient stops breathing, the collar must be removed to enable insertion of a breathing tube, increasing the risk of spinal cord damage. Pressure of the collar on the back of the head can cause pressure sores, and on the root of the neck can increase pressure within the brain, worsening any existing head injury.
We have invented a device providing better immobilisation without preventing mouth opening, leading to a safer experience. It can be applied before the patient is removed from a vehicle increasing safety for patient and paramedic, and can be left on during X-rays and other investigations.
We will train paramedics to use the device and ask volunteers to compare it to current methods by measuring movement of the spine, ability to open the mouth for normal breathing, ability to intubate, measuring risk of pressure sores, and conducting interviews and observations to gather the experience of volunteers and paramedics. Following feedback we will redesign and retest the device, and perform MR scanning that uses magnetic fields and a computer to measure movement between individual neck bones. We believe we have a device that is effective, more comfortable and safer for patients and easier for paramedics to use.
Ethics approval
West Midlands - South, 31/05/2012, ref: 12/WM0098
Study design
Non-randomised observational qualitative study
Primary study design
Observational
Secondary study design
Non randomised controlled trial
Trial setting
Hospitals
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Injuries and Emergencies, Anaesthetics
Intervention
We are testing two versions of the prototype device on healthy volunteers to measure the degree of immobilisation of the head in relation to the shoulders, and the spinal cord, compared to two currently-used devices. We are obtaining the opinions of paramedics trained to apply the device on how it can be improved, and how it compares to their normal experience of applying spinal immobilisation. We are obtaining the opinion of anaesthetists on ease of intubation of a manikin wearing the new and comparator devices.
Intervention type
Device
Phase
Drug names
Primary outcome measures
Prototype testing
Secondary outcome measures
No secondary outcome measures
Overall trial start date
01/07/2012
Overall trial end date
31/05/2013
Reason abandoned
Eligibility
Participant inclusion criteria
1. Healthy volunteers employed by the ambulance service or medical school, or training as a medical student and a willingness to take part in the study
2. Male and female participants
3. Aged 18 - 60 years
Participant type
Healthy volunteer
Age group
Adult
Gender
Both
Target number of participants
UK Sample Size: 140
Participant exclusion criteria
1. For the first prototype testing we shall exclude people who have known neck problem or history of neck surgery, injury to the neck within the previous 12 months
2. Any condition resulting in restriction of neck movement, known claustrophobia, and, for the second prototype testing involving MR scanning
3. People with metallic implants, pacemaker
4. People who are, or may be, pregnant
5. Refusal to sign the confidentiality agreement will be an exclusion criterion
Recruitment start date
01/07/2012
Recruitment end date
31/05/2013
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of Warwick
Coventry
CV4 7AL
United Kingdom
Sponsor information
Organisation
University of Warwick (UK)
Sponsor details
Gibbet Hill Road
Coventry
CV4 7AL
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
NIHR - Invention for Innovation (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