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Warwick Spinal Immobiliser

Warwick Spinal Immobiliser - Development and Initial Trial of Prototype Spinal Immobilisation Device

Specialty
InjuriesEmergencies (co-adopted by Anaesthesia)
Portfolio Eligibility
Automatically eligible
ISRCTN 55006384
EudraCT
MREC N° 12/WM0098
UKCRN ID 12376
WHO ID
Research Summary
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 Xrays 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.
Study Type Observational
Design Type Qualitative
Disease(s) Injuries and Emergencies
All Anaesthesia, perioperative medicine and pain management
Phase Pilot/Feasibility
Current Status Open
Closure Date 12/31/2014
Global Sample Size 140
Global Recruitment to Date
  66%
Geographical Scope UK Multi-Centre
Lead Country England
Open to new sites No
Study Website
Main Inclusion Criteria
There are no specific inclusion criteria other than being a healthy volunteer employed by the ambulance service or medical school, or training as a medical student and a willingness to take part in the study.
Main Exclusion Criteria
For the first phase of 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, any condition resulting in restriction of neck movement, known claustrophobia, and, for the second phase of prototype testing involving MR scanning we shall also exclude those people with metallic implants, pacemaker, or who are, or may be, pregnant. Refusal to sign the confidentiality agreement will be an exclusion criterion.
Chief Investigator(s)
Prof Matthew Cooke
Further details, please contact
Dr Rose Jarvis

Warwick Medical School

Gibbet Hill Road
Coventry
West Midlands
CV4 7AL
UNITED KINGDOM

Tel: 02476 150491
rose.jarvis@warwick.ac.uk
Funder(s) NIHR Invention for Innovation (i4i)
Sponsor(s) University Hospitals Coventry & Warwick
University of Warwick




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