Outcomes of Acute Stroke Patients Requiring Mechanical Ventilation: Study Protocol for the SPICE Multicenter Prospective Observational Study.
BACKGROUND
Care pathways and long-term outcomes of acute stroke patients requiring mechanical ventilation have not been thoroughly studied.


METHODS AND RESULTS
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.


CONCLUSIONS
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.


TRIAL REGISTRATION
NCT03335995.
['Sonneville|R|R|0000-0003-0245-309X', 'Mazighi|M|M|', 'Bresson|D|D|', 'Crassard|I|I|', 'Crozier|S|S|', 'de Montmollin|E|E|', 'Degos|V|V|', 'Faugeras|F|F|', 'Gayat|E|E|', 'Josse|L|L|', 'Lamy|C|C|', 'Magalhaes|E|E|', 'Maldjian|A|A|', 'Ruckly|S|S|', 'Servan|J|J|', 'Vassel|P|P|', 'Vigué|B|B|', 'Timsit|J-F|JF|', 'Woimant|F|F|', '|||']
D005602:France D000085542:Functional Status D000083302:Hemorrhagic Stroke D006801:Humans D007362:Intensive Care Units D000083242:Ischemic Stroke D009026:Mortality D015337:Multicenter Studies as Topic D064887:Observational Studies as Topic D011379:Prognosis D011788:Quality of Life D012121:Respiration, Artificial D020521:Stroke D013345:Subarachnoid Hemorrhage D028761:Withholding Treatment
Outcome Stroke Mechanical ventilation Intensive care unit