Title: Warwick Spinal Immobiliser
Funder: Department of Health (England)

Abstract: Background Spinal Cord Injury (SCI) is rare but has devastating consequences. To reduce the risk of SCI, spinal immobilisation is universally practised in prehospital care of trauma patients. UK figures are hard to obtain, but we estimate that 0.5 million patients receive spinal immobilisation each year. This typically involves a cervical collar/head blocks/tape. We know that current devices do not provide complete immobilisation of the cervical spine. Collars contribute to airway compromise, have the risk of inhalation of vomit, cause pressure sores, increase intracranial pressure due to pressure on the root of the neck, and need to be removed if intubation is required. All these things may increase mortality/morbidity. Some patients suffer marked claustrophobia/ anxiety in current devices. Aims We have designed and patented a device that provides an innovative approach to spinal immobilisation which fully addresses an unmet medical need. Unlike present systems we believe it provides greater than 95% spinal immobilisation and can be fully applied before a patient is moved from a vehicle. Design features give improved mouth opening, better infection control, more comfort and reduced side effects e.g. pressure sores. Currently at proof of concept stage, we need to develop and test a working prototype. Aims: (1) construct a working prototype to be ready for the manufacture stage; (2) demonstrate that the new device provides (a) vastly improved neck immobilisation (b) improved airway control (c) reduced risk of pressure-related tissue injury (d) ease of use and (e) patient comfort. Plan of Investigation We will (1) develop a working prototype and compare its performance to existing technologies. We will compare: (2a) ability to limit spine movement using Cervical Range of Motion device (CROM) and Magnetic Resonance Imaging, (2b) adequacy of airway control by measuring mouth opening and ability to intubate a manikin, (2c) risk of pressure necrosis at skin/device interface using highly sensitive pressure-sensing technology, (2d) qualitative assessment of volunteer experience and comfort, (2e) qualitative and video assessment of paramedic ease of use. We will undertake an iterative process of redesign and re-evaluation of work package 2 to optimise device characteristics. In addition we will analyse market, develop business case to seek industrial collaborator for manufacture and sales. Potential Impact Economic and personal costs of failure to immobilise a potential SCI are enormous, and life expectancy for such patients is reduced. Modern trauma care appropriately assumes that injury is present until excluded, creating a huge demand for effective spinal immobilisation. Our device has many advantages over current options: (1) for the patient: improved outcome after SCI by reducing risk of (a) spinal movement during extrication and risk of paralysis, (b) aspirating vomit (c) developing pressure sores (d) rise in intra-cranial pressure (e) cross-infection (f) claustrophobia and discomfort. (2) for the NHS: decreased (a) costs associated with paraplegia (b) bed usage by paraplegic patients (c) litigation costs and (d) better utilisation and safety of paramedics at the accident scene.


Research activity codes: 5.3 MEDICAL DEVICES
Health categories: INJURIES AND ACCIDENTS