Comparison Between the IMPACT's Score and the Clinician's Perception to Predict the Prognosis of Traumatic Brain Injury.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 83
- 试验地点
- 2
- 主要终点
- 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.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
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.
时间窗: 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.
次要结局
- 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)
- Evaluate how the clinician's confidence in his prognosis is related to the quality of the prognosis.(At 6 months)
- Differences in prognosis between clinicians based on their experience and specialty.(At 6 months)