Traumatic Brain Injury
Conditions
Keywords
Severe and moderate traumatic brain injury, Prognosis, IMPACT score
Brief summary
Main objective : To compare the quality of the prognostic assessment, (adverse evolution at 6 months) of severe and moderate traumatic brain injury, performed by the clinician compared to the prognosis described by the IMPACT score. The Pitié-Salpêtrière hospital is conducting a study evaluating the clinician's prognostic assessment of severe and moderate traumatic brain injury compared to the prognosis described by the IMPACT score. The investigators compare the quality of the clinician's prognostic assessment (adverse evolution at 6 months) of severe and moderate traumatic brain injury to the prognosis described by the IMPACT score.
Detailed description
Design: Prospective, monocentric, pilot study. The study will be proposed to all patients admitted to the neurosurgical intensive care unit (ICU) at Pitié-Salpêtrière hospital, following a traumatic brain injury (TBI), over a period of 1 year. Around 100 patients will be included. Day 1 : In the first 24 hours after traumatic brain injury, two clinicians will respond to the research questionnaire assessing their patient's prognosis, including confidence in their prediction and experience in neurological intensive care unit. The known prognostic variables as the IMPACT score in the first 24 hours will be collected. Day 7 : The same clinicians will respond to the research questionnaire assessing their patient's prognosis, including confidence in their prediction and experience in neurological intensive care unit. At 6 months : After 6 months, all patients or relatives will undergo a telephone interview (or if applicable during a follow-up visit in standard care) to assess the Glasgow Outcome Scale (GOS). This interview will be blinded to the clinician's prediction and the IMPACT score. For patients identified as GOS 3 or 4, a second GOS telephone interview will be carry out in the following days (\<7 days), by a committee of adjudication composed of 2 examiners.
Interventions
OTHERQuestionnaire
* Two clinicians will complete a questionnaire that analyses their perception of the patient's prognosis at Day1 and Day7. * At 6 months, another clinician will establish the patient prognosis using Glasgow Outcome Scale and Glasgow outcome scale extended. This clinician must not know the patient's IMPACT score and prognosis established at Day 1 and Day 7. His evaluation will be compare to the patient's prognosis established previously (Day1 and Day7).
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient aged 18 years or older, * Hospitalized in the neurosurgical ICU department of the Pitié-Salpêtrière hospital following a head trauma, * Presenting a Glasgow Coma Scale (GCS) ≤ 12 in the first 24 hours following the head trauma, * Relatives informed of the research and not having objected to the patient's participation in the study.
Exclusion criteria
* Opposition of the patient, * Patient under the protection of justice, * Pregnant woman, * Modified scale of Rankin\> 1 before the traumatic brain injury. * Patient unable to speak French.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Compare the quality of the prognostic assessment of severe and moderate traumatic brain injury, performed by the clinician compared to the prognosis described by the IMPACT score. | At 6 month | Comparison of the area under the ROC curve of the IMPACT model score for the prediction of the 6-month Glasgow Outcome Scale (GOS) ≤ 3 to the area under the ROC curve of the first day clinician's prediction. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Differences in prognosis between clinicians based on their experience and specialty. | At 6 months | Evaluation of the effect of the clinician's experience (number of years of neuro-ICU exercise) and specialty on the clinician's prognosis ROC curve. |
| To compare the quality of the prognosis of the clinicians between the 1st day (D1) and the 7th day (D7) post-traumatic. | At 6 months | Comparison between the clinician's ROC curves at D1 (between the 6th and the 24th hour) and at D7 of the trauma for the prognosis of the patient. |
| Evaluate how the clinician's confidence in his prognosis is related to the quality of the prognosis. | At 6 months | Evaluation of the effect of the clinician's confidence in his prognosis on the clinician's prognostic ROC curve. |
Countries
France
Outcome results
None listed