INSERM UMR1148, Team 6, Université de Paris, 75018, Paris, France.
APHP, Department of Intensive Care Medicine, Bichat-Claude Bernard University Hospital, 46 Rue Henri Huchard, 75018, Paris, France.
Neurocrit Care. 2020 Apr;32(2):624-629. doi: 10.1007/s12028-019-00907-0.
Care pathways and long-term outcomes of acute stroke patients requiring mechanical ventilation have not been thoroughly studied.
Stroke Prognosis in Intensive Care (SPICE) is a prospective multicenter cohort study which will be conducted in 34 intensive care units (ICUs) in the Paris, France area. Patients will be eligible if they meet all of the following inclusion criteria: (1) age of 18 years or older; (2) acute stroke (i.e., ischemic stroke, intracranial hemorrhage, or subarachnoid hemorrhage) diagnosed on neuroimaging; (3) ICU admission within 7 days before or after stroke onset; and (4) need for mechanical ventilation for a duration of at least 24 h. Patients will be excluded if they meet any of the following: (1) stroke of traumatic origin; (2) refusal to participate; and (3) privation of liberty by administrative or judicial decision. The primary endpoint is poor functional outcome at 1 year, defined by a score of 4 to 6 on the modified Rankin scale (mRS), indicating severe disability or death. Main secondary endpoints will include decisions to withhold or withdraw care, mRS scores at 3 and 6 months, and health-related quality of life at 1 year.
The SPICE multicenter study will investigate 1-year outcomes, ethical issues, as well as care pathways of acute stroke patients requiring invasive ventilation in the ICU. Gathered data will delineate human resources and facilities needs for adequate management. The identification of prognostic factors at the acute phase will help to identify patients who may benefit from prolonged intensive care and rehabilitation.
NCT03335995.
需要机械通气的急性脑卒中患者的护理路径和长期结局尚未得到充分研究。
卒中重症监护预后（SPICE）是一项前瞻性多中心队列研究，将在法国巴黎地区的 34 个重症监护病房（ICU）进行。如果患者符合以下所有纳入标准，则符合入选条件：（1）年龄 18 岁或以上；（2）神经影像学诊断为急性脑卒中（即缺血性脑卒中、颅内出血或蛛网膜下腔出血）；（3）在脑卒中发病前 7 天或脑卒中发病后 ICU 入院；（4）需要机械通气至少 24 小时。如果患者符合以下任何标准，则不符合入选条件：（1）创伤性脑卒中；（2）拒绝参与；（3）行政或司法决定剥夺自由。主要终点是 1 年时的不良功能结局，定义为改良 Rankin 量表（mRS）评分为 4 至 6，表明严重残疾或死亡。主要次要终点将包括放弃或停止治疗的决定、3 个月和 6 个月时的 mRS 评分以及 1 年时的健康相关生活质量。
SPICE 多中心研究将调查需要在 ICU 进行有创通气的急性脑卒中患者的 1 年结局、伦理问题以及护理路径。收集的数据将描绘出人力资源和设施需求，以进行充分的管理。在急性期识别预后因素将有助于识别可能受益于延长重症监护和康复的患者。
NCT03335995。
