Spinal Immobilisation Study (SIS)

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?

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.

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.

TARGET POPULATION: Pre-hospital based patients with a potential cervical spine injury (pre-imaging) following blunt trauma.

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.

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) HEALTH TECHNOLOGY BEING ASSESSED:

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. Control: Cervical collar, head blocks and tape (as per NICE guidelines).

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.

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.

FOLLOW UP: Up to 6 months post-randomisation.

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).

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.

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.