R Sonneville1,2, M Mazighi3,4,5, D Bresson6, I Crassard4,7, S Crozier8, E de Montmollin9,10, V Degos11,12, F Faugeras13,14, E Gayat15,16, L Josse17, C Lamy18,19, E Magalhaes20, A Maldjian21, S Ruckly9,10, J Servan22, P Vassel23, B Vigué24, J-F Timsit9,10, F Woimant4,7. 1. INSERM UMR1148, Team 6, Université de Paris, 75018, Paris, France. romain.sonneville@aphp.fr. 2. APHP, Department of Intensive Care Medicine, Bichat-Claude Bernard University Hospital, 46 Rue Henri Huchard, 75018, Paris, France. romain.sonneville@aphp.fr. 3. INSERM UMR1148, Team 6, Université de Paris, 75018, Paris, France. 4. Department of Neurology, Lariboisière University Hospital, Assistance Publique - Hôpitaux de Paris, Paris, France. 5. Department of Neuroradiology, Rothschild Hospital, Paris, France. 6. Department of Neurosurgery, Henri Mondor University Hospital, Assistance Publique - Hôpitaux de Paris, Paris, France. 7. Agence Régionale de Santé, Paris, France. 8. Department of Neurology, Pitié-Salpétrière University Hospital, Assistance Publique - Hôpitaux de Paris, Paris, France. 9. APHP, Department of Intensive Care Medicine, Bichat-Claude Bernard University Hospital, 46 Rue Henri Huchard, 75018, Paris, France. 10. INSERM UMR1137, Team 6, Université de Paris, 75018, Paris, France. 11. Department of Critical Care, Anesthesia and Perioperative Medicine, Pitié-Salpétrière Hospital, Assistance Publique - Hôpitaux de Paris-Sorbonne University, Paris, France. 12. GRC ARPE, Sorbonne University, Paris, France. 13. Department of Neurology, Henri Mondor University Hospital, Assistance Publique - Hôpitaux de Paris, Créteil, France. 14. INSERM U955, Institut Mondor de Recherche Biomédicale, EQuipe E01 Neuropsychologie Interventionnelle, 94000, Créteil, France. 15. Department of Anesthesiology and Critical Care, DMU Parabol, APHP Nord, Université de Paris, Paris, France. 16. UMR-S 942, Inserm, MASCOT, Paris, France. 17. Department of Rehabilitation Medicine, Fernand Widal University Hospital, Assistance Publique - Hôpitaux de Paris, Paris, France. 18. Department of Neurology, Saint Anne Hospital, Paris, France. 19. INSERM U1266, Université Paris Descartes, Paris, France. 20. Department of Intensive Care Medicine, Sud Francilien Hospital, Corbeil, France. 21. Department of Rehabilitation Medicine, 317 Lostihuel Braz, 56250, Sulniac, France. 22. Department of Neurology, André Mignot Hospital, Le Chesnay, France. 23. Department of Rehabilitation Medicine, Le Parc, Pontault-Combault, France. 24. Department of Anesthesiology and Critical Care, Kremlin Bicêtre University Hospital, Assistance Publique - Hôpitaux de Paris, Paris, France.
Abstract
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.
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.
Entities:
Keywords:
Intensive care unit; Mechanical ventilation; Outcome; Stroke
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