Outcomes of Acute Stroke Patients Requiring Mechanical Ventilation: Study Protocol for the SPICE Multicenter Prospective Observational Study
Autor: | Mikael Mazighi, C Lamy, P Vassel, Spice investigators, B Vigué, J-F Timsit, A Maldjian, J Servan, Romain Sonneville, F Faugeras, Etienne Gayat, Eric Magalhaes, I Crassard, D Bresson, Vincent Degos, F Woimant, S Crozier, E de Montmollin, Stéphane Ruckly, L Josse |
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Rok vydání: | 2020 |
Předmět: |
Mechanical ventilation
medicine.medical_specialty business.industry medicine.medical_treatment 030208 emergency & critical care medicine Critical Care and Intensive Care Medicine medicine.disease Intensive care unit law.invention 03 medical and health sciences 0302 clinical medicine Quality of life (healthcare) Modified Rankin Scale law Intensive care Emergency medicine medicine Clinical endpoint Neurology (clinical) business Stroke 030217 neurology & neurosurgery Cohort study |
Zdroj: | Neurocritical Care. 32:624-629 |
ISSN: | 1556-0961 1541-6933 |
Popis: | 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. Trial registration: NCT03335995. |
Databáze: | OpenAIRE |
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