Title: Spinal Immobilisation Study (SIS)
Funder: Department of Health and Social Care

Abstract: AIM:_x000D_ To assess whether movement minimisation is no worse than triple spinal immobilisation for patients who have may have or are suspected of a spinal injury in the pre-hospital and emergency setting._x000D_ _x000D_ BACKGROUND:_x000D_ Spinal cord damage often occurs as a result of road traffic crashes, sports injury or as a result of a low-level fall in frail people. Although the incidence of spinal cord injury is rare, if it occurs, it can have a dramatic effect on an individual’s quality of life and can lead to long term disability or even death._x000D_ _x000D_ In the UK, when a potential traumatic spinal injury occurs, the current practice is that the ambulance paramedics will place the patient on a rigid board or mattress and strap them down using tape supported by blocks and/or a hard neck collar. This reduces any movement and the patient is made to stay still, to prevent more damage to the spine during transfer to hospital. This is known as triple spinal immobilisation. There is some concern that this can harm more than it helps patients (e.g. difficulty in breathing, skin or brain injury, aggravate spine injury in rare instances)._x000D_ _x000D_ By altering some of the aspects of triple immobilisation, we can introduce some flexibility, such that the patient is more comfortable and there may be fewer side effects. Managing patients in this way is known as "movement minimisation". At present we don’t know if movement minimisation will improve or worsen spinal problems (such as paralysis) and potential complications of the usual methods such as breathing in vomit (aspiration), skin problems and brain injury. This research was ranked in the top 10 Emergency Care Research Questions by the James Lind Alliance Emergency Medicine Research Priority Setting Partnership in 2017._x000D_ _x000D_ DESIGN AND METHODS:_x000D_ In total, about 8316 patients will be put into these two immobilisation groups at random. We will use information about them to ensure that the groups are similar (in terms of injury severity, gender and age). We will assess their nerve function at injury, when they arrive and leave hospital. We will also look to see what side effects these patients have had and collect information during and after they have left hospital (6 months later) to assess their well-being, in terms of movement and general health. We will initially do the study in 800 patients to ensure that a larger trial is feasible._x000D_ _x000D_ PATIENT AND PUBLIC INVOLVEMENT:_x000D_ We are working closely with 2 Patient and Public Involvement groups – ASPIRE and the Imperial Trauma PPI group,the leads of both are co-applicants. As well as spinal patients we have trauma patients who have experienced immobilisation and subsequently found to not have spinal injury. The groups have emphasised the important need for the research before guideline change, helped the study design (especially primary outcome) and continue to support the ethics and patient information processes. Their continued review and analysis of the results will be extremely valuable in shaping recommendations and guidelines. _x000D_ _x000D_ DISSEMINATION:_x000D_ Our plan includes sharing the results with patients, the public, paramedics, doctors and nurses internationally. We will do this through presenting the work at medical conferences, social media, podcasts, written reports and scientific publications. We will work closely with our colleagues in professional organisations to ensure that our findings contribute to future NHS guidelines.

Lay abstract: RESEARCH QUESTION: Is movement minimisation non-inferior (i.e. not unacceptably worse) compared to triple immobilisation in relation to functional outcome (as assessed by the Functional Independence Measure motor scale) at hospital discharge and at 30 days following randomisation?_x000D_ _x000D_ DESIGN: Multi-centre, open label, randomised controlled non-inferiority clinical & cost effectiveness trial with an internal pilot and process evaluation. Progression and success criteria from pilot to main study will be assessed on recruitment. _x000D_ _x000D_ SETTING: Six to 8 UK ambulance services, who manage adults and children with traumatic injuries, who have a proven track record of successful participation in clinical trials._x000D_ _x000D_ TARGET POPULATION: Pre-hospital based patients with a potential cervical spine injury (pre-imaging) following blunt trauma._x000D_ _x000D_ INCLUSION CRITERIA: 1) Out of hospital with treatment being provided by NHS Ambulance Service staff; 2) Patient assessed & found to require spinal immobilisation according to NHS Ambulance guidelines; 3) Any Glasgow Coma Score; 4) Transfer planned to participating ED._x000D_ _x000D_ EXCLUSION CRITERIA: 1) Patients not requiring require spinal immobilisation according to NHS Ambulance guidelines; 2) Patients in whom placing a collar is contraindicated (e.g. pre-existing deformity)_x000D_ _x000D_ HEALTH TECHNOLOGY BEING ASSESSED: _x000D_ Intervention: Movement minimisation [head blocks or rolled blankets to minimise movement in coronal plane, allow to sit up on ambulance stretcher] and “c-spine not cleared” sticker._x000D_ Control: Cervical collar, head blocks and tape (as per NICE guidelines)._x000D_ _x000D_ MEASUREMENT OF COSTS AND OUTCOMES: Outcomes will be assessed at discharge, 30 days and 6 (180 days) months after randomisation. The primary clinical outcome for the study will be the FIM-motor score at hospital discharge and at 30 days. _x000D_ _x000D_ The secondary outcomes will comprise measurement of ASIA Impairment scale (neurological deterioration); mortality; critical and hospital stay; adverse events (aspiration / pressure sores / ICP rise); interventions used for c-spine injury; discharge destination; EQ-5D-5L (quality of life utility). The health economic evaluation will compare costs and assess within-trial and lifetime cost-effectiveness from an NHS and personal social services (PSS) perspective._x000D_ _x000D_ FOLLOW UP: Up to 6 months post-randomisation._x000D_ _x000D_ SAMPLE SIZE: 8316 in total, allowing for 2-point difference in the FIM score, to declare non-inferiority between the interventions (at 90% power and 5% type I error; SD =25.93). _x000D_ _x000D_ PROJECT TIMELINE: Six month set-up leading to a 6 month pilot. Assuming all pre-defined milestones, the 18 month main trial will continue (total 24 months recruiting). Six months follow up and 6 months analysis and reporting. Total project duration is 42 months._x000D_ _x000D_ EXPERTISE: A multi-disciplinary team of international experts in trauma injury, clinical trialists, clinicians and patient representatives with a strong track record in large-scale pre-hospital and critical care medicine will support the trial. The trial will be led by senior professorial staff - clinical (MW, GDP, FL, RF, PH); statistics (RL), health economics (JM), VOI (MS) supported by experienced trial management team (senior project manager, trial manager, programming) from Warwick CTU in partnership with Imperial (training, site set-up, governance, contracting). The National Ambulance Research Steering Group (representing all NHS Ambulance Services) strongly support this trial.

Research activity codes: 6.3 MEDICAL DEVICES
Health categories: INJURIES AND ACCIDENTS