Early Ultrasound Screening of Heterotopic Ossification After Severe Neurological Trauma in a Post-intensive Care Rehabilitation Unit
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Area under the ROC (receiver operating characteristic) curve at 1 week
研究概览
简要总结
Prospective, bi-centric diagnostic, performance study on a new diagnostic procedure with ultrasounds against a reference diagnostic procedure.
The primary objective is to study the performance of ultrasound coupled with clinical examination at 1 week of admission for early screening of heterotopic ossification (HO) in patients admitted to a post intensive care rehabilitation unit (PICRU) after a severe neurologic trauma.
The CT scan at 5 weeks of admission is considered as the gold standard. CT scan reader will be blinded to clinical data.
详细描述
Heterotopic ossification still pose the problem of diagnosis and clinical management that is too late and invasive when complications arise. The challenge would be to identify patients at earlier stage of HO development in order to start an early treatment. This study will focus on the performance of ultrasound in the early screening of HO for patients admitted to a post intensive care rehabilitation unit after severe neurological trauma, this population being at high risk of HO.
Patient enrollment will be performed only at the PICRU of the Raymond Poincaré Hospital (AP-HP). Another center (the imaging department of the same hospital) will participate in this research for ultrasounds and CT scans, but will not perform any recruitment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients ⩾ 18 years;
- •Admitted to a neurological post intensive care rehabilitation unit for the first time;
- •Hospitalized in ICU before being admitted to PICRU for a for traumatic brain injury (initial Glasgow coma scale < 14 and brain radiological abnormalities at the time of admission to ICU and / or a traumatic spinal cord injury (para- or tetraplegia with at least half of key muscles of the 2019 ISNCSCI classification with a strength of less than 3 below the neurological level of the injury at the time of admission to PICRU);
- •Patient's written consent obtained (or from an authorized relative);
- •Affiliation to a social security scheme.
排除标准
- •History of moderate or severe traumatic brain injury;
- •History of spinal cord injury (para- or tetraplegia);
- •History of stroke or disabling neurological disease;
- •History of hospitalization in neurological or neurosurgical or traumatological ICU for another reason;
- •Breast-feeding or pregnancy;
- •Under court protection.
结局指标
主要结局
Area under the ROC (receiver operating characteristic) curve at 1 week
时间窗: at 1 week
Area under the ROC curve of ultrasound examination at 1 week compared CT scan at 5 weeks for making the diagnosis of HO.
次要结局
- Sensitivity(at 1 week)
- Specificity(at 1 week)
- Positive predictive value and negative predictive value(at 1 week)
- Likelihood-ratio of ultrasound(at 1 week)
- Area under the ROC curve at 5 weeks(at 5 weeks)
- Clinical examination(weekly from week-1 to week-5)