Injuries and accidents Injury, Occupational Diseases, Poisoning
Conditions
Interventions
This trial is a prospective randomised non-inferiority trial which means we will study patients who, according to current guidelines require cervical spine immobilisation, randomly assigning them to t
Sponsors
Imperial College London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Out of hospital with treatment being provided by NHS Ambulance Service staff 2. Patient assessed and found to require spinal immobilisation according to NHS Ambulance guidelines 3. Any Glasgow Coma Score 4. Transfer planned to the participating emergency department
Exclusion criteria
Exclusion criteria: 1. Patients not requiring spinal immobilisation according to NHS Ambulance guidelines 2. Patients in whom placing a collar is contraindicated (e.g. pre-existing deformity)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Level of disability in terms of burden of care measured using the total Functional Independence Measurement motor (FIM-motor) score at hospital discharge and at 30 days post-injury | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary effectiveness outcomes: 1. Level of disability measured using FIM-motor score at discharge, 30 days, 180 days after randomisation at video clinic or follow-up appointment 2. Level of disability and cognition measured using the total FIM-total score and cognition scales at discharge, 30 days and 180-day at video clinic or follow-up appointment 3. Sensory and motor levels measured using the American Spinal Injury Association (ASIA) impairment scale from randomisation to discharge 4. Mortality measured using patient medical notes at days 30, 90 and 180 5. Intervention for cervical spinal cord injury in the first 30 days or discharge measured using patient medical notes for use of collar for > 2 weeks, halo brace, and cervical spine surgery from randomisation to discharge 5. Discharge destination measured using patient medical notes at discharge 6. Pre-hospital analgesic requirements measured using patient medical notes from the Ambulance Patient Report Form onwards Secondary safety outcomes: Adverse events (pressure sores, aspiration pneumonia, intracranial hypertension) measured using patient medical notes from randomisation to discharge Other secondary outcomes: Primary Health Care System benefit measure: Resource use including intervention, hospital (ICU, HDU and ward days) and community costs (primary care and social care costs) in the 6 months following the intervention. Resources will be costed using national reference unit costs where available, reflated to current prices. Secondary Health Care System benefit measures measured using patient medical notes at the end of the study: 1. Critical care unit length and level of stay 2. Hospital length of stay 3. Re-admissions to the hospital Utilisation of resource use: 1. Utilisation of community care resources measures using patient medical notes after acute hospital discharge to 6 months after randomisation 2. Health-related quality of life measured using the EuroQol EQ-5D-5L at discharge, 30 da | — |
Countries
England, United Kingdom, Wales
Contacts
Public ContactSIS Trial
Outcome results
None listed