Mild traumatic brain injury Injury, Occupational Diseases, Poisoning
Conditions
Interventions
The purpose of this study is to establish the feasibility of a fully powered diagnostic test accuracy study to evaluate the accuracy of the Canadian CT head rule (CCHR) when applied by paramedics in t
Sponsors
University of Manchester
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adult patients aged 16 years old and over who receive an emergency ambulance response for a primary complaint of head injury 2. Glasgow coma scoring (GCS) of 13–15 at the time of assessment by treating paramedics 3. Patients who will be transported to the hospital as part of their routine clinical care
Exclusion criteria
Exclusion criteria: 1. Already received care in hospital for their condition and who are undergoing secondary transfer to a specialist centre 2. Penetrating skull injury 3. Trauma to other body regions that would require transport to the hospital 4. Prisoners
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility outcomes: 1. Number of eligible patients approached measured using screening logs and case report forms throughout the enrolment period 2. Proportion of patients approached who consent to participate in the study measured using screening logs and case report forms throughout the enrolment period 3. Completeness of data collection measured using screening logs and case report forms throughout the enrolment period 4. Completeness of follow-up measured using case report forms following hospital discharge or death (if in-hospital) 5. Determination of the inter-observer reliability of the Canadian CT head rule completion between prehospital care providers (during the prehospital phase) and ED physicians (while patients are in the Emergency Department) measured using case report forms 6. Determination of the inter-observer reliability of each component of the Canadian CT head rule between prehospital care providers (in the prehospital phase) and ED physicians (while patients are in the ED) measured using case report forms 7. The diagnostic performance of the Canadian CT head rule, as assessed by paramedics in the prehospital phase, using patient records and case report forms 8. The acceptability of trial processes to patients and paramedics measured using a qualitative approach and clinical sensibility of the Canadian CT head rule measured using a survey method | — |
Secondary
| Measure | Time frame |
|---|---|
| Presence of traumatic intracranial lesion requiring neurosurgical intervention, defined as any neurosurgical intervention and/or abnormal head CT findings and/or death within 7 days as a result of traumatic brain injury measured using medical records at 7 days after initial admission | — |
Countries
England, United Kingdom
Outcome results
None listed