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Outcomes of Acute Stroke Patients Requiring Mechanical Ventilation: Study Protocol for the SPICE Multicenter Prospective Observational Study

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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.

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Data Statement

The raw/processed data required to reproduce these findings cannot be shared at this time as the data also form part of an ongoing study.

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Acknowledgments

We thank Perrine Boursin, research nurse, Fariza Lamara, clinical research assistant, and Corinne Dutheil, medical secretary, for their help in data collection and follow-up of patients.

Scientific Committee

Prof Damien Bresson, Dr Sophie Crozier, Prof Vincent Degos, Dr Frédéric Faugeras, Prof Etienne Gayat, Dr Carole Imbernon, Dr Laurence Josse, Dr Catherine Lamy, Dr Alain Maldjian, Prof Mikael Mazighi, Dr Eric Magalhaes, Dr Etienne de Montmollin, Stéphane Ruckly, Dr Jérôme Servan, Prof Romain Sonneville, Prof Jean-François Timsit, Dr Philippe Vassel, Dr Bernard Vigue, Dr France Woimant.

Steering Committee

Agence Régionale de Santé (ARS) Ile-de-France, Club NeuroVasculaire Ile-de-France, Institut National de la Santé et de la Recherche Médicale (INSERM), Observatoire Régional de Santé Ile-de-France, Programme de Médicalisation des Systèmes d’Information (PMSI). Prof Philippe Azouvi, Dr Catherine Broutin, Dr Isabelle Crassard, Dr Catherine Lamy, Arnaud Le Merrer, Dr Eric Magalhaes, Prof Mikael Mazighi, Prof Romain Sonneville, Maylis Telle-Lamberton, Prof Jean-François Timsit, Dr Philippe Vassel, Dr France Woimant.

Collaborators (SPICE investigators)

Lionel Kerhuel, Médecine intensive—réanimation, Hôpital Saint-Louis, Paris.

Grégory Papin, Médecine intensive—réanimation, Hôpital Bichat, Paris.

Charles Gregoire, Réanimation polyvalente, Fondation O.de Rothschild, Paris.

Nathalie Rolin, Médecine intensive—réanimation, Hôpital Marc Jacquet, Melun.

Eric Magalhaes, Médecine intensive—réanimation, CH Sud Francilien, Corbeil.

Pierre Pasquier, Médecine intensive—réanimation, Hôpital Percy, Clamart.

Damien Roux, Médecine intensive—réanimation, Hôpital Louis Mourier, Colombes.

Magalie Collet, Réanimation chirurgicale, Hôpital Lariboisière, Paris.

Bruno Megarbane, Médecine intensive—réanimation, Hôpital Lariboisière, Paris.

Marie-Hélène Pari, Réanimation neurochirurgicale, GH Pitié Salpêtrière, Paris.

Alexandre Demoule, Médecine intensive—réanimation, GH Pitié Salpêtrière, Paris.

Loic Le Guennec, Médecine intensive—réanimation, GH Pitié Salpêtrière, Paris.

Cédric Bruel, Médecine intensive—réanimation, CH Saint Joseph, Paris

Jacques Duranteau, Réanimation chirurgicale, CHU Kremlin Bicêtre, Paris.

Éric Delpierre, Médecine intensive—réanimation, CH de Meaux.

Jonathan Zarka, Médecine intensive—réanimation, CH de Jossigny.

Mathilde Lermuzeaux, Réanimation, CH de Saint Denis.

Catherine Paugam-Burtz, Réanimation chirurgicale, Hôpital Beaujon, Clichy.

Paul-Henri Jost, Réanimation chirurgicale, Hôpital Henri Mondor, Créteil.

Karim Toumert, Médecine intensive—réanimation, CH de Gonesse.

David Cortier, Réanimation, Hôpital Foch, Suresnes.

Stéphane Legriel, Médecine intensive—réanimation, CH de Versailles.

Guillaume Geri, Médecine intensive—réanimation, CHU Ambroise Paré, Boulogne.

Omar Ben Hadj Salem, Médecine intensive—réanimation, Hôpital de Poissy.

Jean-Paul Mira, Médecine intensive—réanimation, Hôpital Cochin, Paris.

Jean-Luc Diehl, Médecine intensive—réanimation, Hôpital Européen Georges Pompidou, Paris.

Romain Pirracchio, Réanimation chirurgicale, hôpital Européen Georges Pompidou, Paris.

François Bagate, Médecine intensive—réanimation, hôpital Henri Mondor, Créteil.

Éric Barre, Médecine intensive—réanimation, Hôpital François Quesnay, Mantes la Jolie.

Tarek Sharshar, Réanimation neurochirurgicale, hôpital Saint-Anne, Paris.

Sophie Demeret, Réanimation neurologique, hôpital Pitié-Salpêtrière, Paris.

Sébastien Tanaka, Réanimation chirurgicale, hôpital Bichat, Paris.

Funding

This work was supported by Agence Régionale de Santé (ARS), Ile de France.

Author information

Author notes

  1. R. Sonneville and M. Mazighi have contributed equally to this work.

Authors and Affiliations

  1. INSERM UMR1148, Team 6, Université de Paris, 75018, Paris, France

    R. Sonneville & M. Mazighi

  2. APHP, Department of Intensive Care Medicine, Bichat-Claude Bernard University Hospital, 46 Rue Henri Huchard, 75018, Paris, France

    R. Sonneville, E. de Montmollin, S. Ruckly & J-F. Timsit

  3. Department of Neurology, Lariboisière University Hospital, Assistance Publique – Hôpitaux de Paris, Paris, France

    M. Mazighi, I. Crassard & F. Woimant

  4. Department of Neuroradiology, Rothschild Hospital, Paris, France

    M. Mazighi

  5. Department of Neurosurgery, Henri Mondor University Hospital, Assistance Publique – Hôpitaux de Paris, Paris, France

    D. Bresson

  6. Agence Régionale de Santé, Paris, France

    I. Crassard & F. Woimant

  7. Department of Neurology, Pitié-Salpétrière University Hospital, Assistance Publique – Hôpitaux de Paris, Paris, France

    S. Crozier

  8. INSERM UMR1137, Team 6, Université de Paris, 75018, Paris, France

    E. de Montmollin, S. Ruckly & J-F. Timsit

  9. Department of Critical Care, Anesthesia and Perioperative Medicine, Pitié-Salpétrière Hospital, Assistance Publique – Hôpitaux de Paris-Sorbonne University, Paris, France

    V. Degos

  10. GRC ARPE, Sorbonne University, Paris, France

    V. Degos

  11. Department of Neurology, Henri Mondor University Hospital, Assistance Publique – Hôpitaux de Paris, Créteil, France

    F. Faugeras

  12. INSERM U955, Institut Mondor de Recherche Biomédicale, EQuipe E01 Neuropsychologie Interventionnelle, 94000, Créteil, France

    F. Faugeras

  13. Department of Anesthesiology and Critical Care, DMU Parabol, APHP Nord, Université de Paris, Paris, France

    E. Gayat

  14. UMR-S 942, Inserm, MASCOT, Paris, France

    E. Gayat

  15. Department of Rehabilitation Medicine, Fernand Widal University Hospital, Assistance Publique – Hôpitaux de Paris, Paris, France

    L. Josse

  16. Department of Neurology, Saint Anne Hospital, Paris, France

    C. Lamy

  17. INSERM U1266, Université Paris Descartes, Paris, France

    C. Lamy

  18. Department of Intensive Care Medicine, Sud Francilien Hospital, Corbeil, France

    E. Magalhaes

  19. Department of Rehabilitation Medicine, 317 Lostihuel Braz, 56250, Sulniac, France

    A. Maldjian

  20. Department of Neurology, André Mignot Hospital, Le Chesnay, France

    J. Servan

  21. Department of Rehabilitation Medicine, Le Parc, Pontault-Combault, France

    P. Vassel

  22. Department of Anesthesiology and Critical Care, Kremlin Bicêtre University Hospital, Assistance Publique – Hôpitaux de Paris, Paris, France

    B. Vigué

Authors
  1. R. Sonneville
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  2. M. Mazighi
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  3. D. Bresson
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  4. I. Crassard
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  5. S. Crozier
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  6. E. de Montmollin
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  7. V. Degos
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Consortia

the SPICE investigators

  • Lionel Kerhuel
  • , Grégory Papin
  • , Charles Gregoire
  • , Nathalie Rolin
  • , Eric Magalhaes
  • , Pierre Pasquier
  • , Damien Roux
  • , Magalie Collet
  • , Bruno Megarbane
  • , Marie-Hélène Pari
  • , Alexandre Demoule
  • , Loic Le Guennec
  • , Cédric Bruel
  • , Jacques Duranteau
  • , Éric Delpierre
  • , Jonathan Zarka
  • , Mathilde Lermuzeaux
  • , Catherine Paugam-Burtz
  • , Paul-Henri Jost
  • , Karim Toumert
  • , David Cortier
  • , Stéphane Legriel
  • , Guillaume Geri
  • , Omar Ben Hadj Salem
  • , Jean-Paul Mira
  • , Jean-Luc Diehl
  • , Romain Pirracchio
  • , François Bagate
  • , Éric Barre
  • , Tarek Sharshar
  • , Sophie Demeret
  •  & Sébastien Tanaka

Contributions

RS, MM, JFT, IC, and FW designed the work. All investigators were involved in patients’ recruitment and data collection. SR is responsible for data management and statistical analyses. RS and MM wrote the manuscript. JFT, EG, FF, IC, and FW revised the manuscript. All authors read and approved the final manuscript.

Corresponding author

Correspondence to R. Sonneville.

Ethics declarations

Conflicts of interest

The authors declare that they have no conflict of interest.

Ethical approval

The whole protocol has been reviewed and approved by the comité de protection des personnes sud méditerranée 1 (ID RCB 2017-A02452-51).

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Sonneville, R., Mazighi, M., Bresson, D. et al. Outcomes of Acute Stroke Patients Requiring Mechanical Ventilation: Study Protocol for the SPICE Multicenter Prospective Observational Study. Neurocrit Care 32, 624–629 (2020). https://doi.org/10.1007/s12028-019-00907-0

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  • DOI: https://doi.org/10.1007/s12028-019-00907-0

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