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CompletedNCT03335995SPICEUpdated Oct 3, 2025

Stroke Prognosis in Intensive CarE

An observational study in Acute Stroke Patients Requiring Invasive Mechanical Ventilation, sponsored by Institut National de la Santé Et de la Recherche Médicale, France. Completed at 1 site in France. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2025-10-03.

Sponsored by Institut National de la Santé Et de la Recherche Médicale, France · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
364
Ages
18 Years to 85 Years
Sex
All
01

Study summary

The S.P.I.C.E registry is an investigator-initiated prospective multicenter cohort study which will be conducted in 35 ICUS in the Paris area.The aim of the study is to determine the trajectory of acute stroke patients requiring invasive mechanical ventilation, focusing on functional outcomes at 3 months and 1 year following ICU admission. This project is funded by the French Agence Régionale de Santé (ARS).

02

Conditions studied

  • Acute Stroke Patients Requiring Invasive Mechanical Ventilation

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Keywords

  • mechanical invasive ventilation
  • course of the care
  • prognosis
  • stroke
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Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

The subjects included in this study are adult patients requiring invasive mechanical ventilation at the acute phase of stroke (within 7 days of stroke onset), irrespective of indication for intubation.

Prolonged mechanical ventilation of several days to weeks in ICU may be required for some patients, with various ICU discharge trajectories in survivors.

Inclusion criteria

  • Age>18 years
  • Acute stroke (acute ischaemic stroke, brain hemorrhage, subarachnoid hemorrhage). The stroke diagnosis date is defined by the date of the initial brain imaging (TDM or MRI).
  • Admitted to ICU within 7 days before or after the diagnosis of stroke.
  • Requiring invasive mechanical ventilation in ICU for more than 24 hours.

Exclusion criteria

Exclusion criteria:

  • Traumatic causes of stroke
  • Refusal of the patient, or his reliable person, to participate in the study.
  • Privation of liberty by administrative or judicial decision
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
364 participants (actual)
Patient registry
No
05

What researchers measure

Primary outcomes

  1. Functional outcome

    Score on the modified Rankin scale (a disability score that ranges from 0 \[no symptoms\] to 6 \[death\]). Patients will be classified as "good outcome" (score of 0-3) or poor outcome (score of 4-6, indicating severe disability or death).

    Time frame: One year

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Study locations

1 site
  • Bichat Hospital
    Paris, 75018, France
07

References and documents

Publications

  • Sonneville R, Mazighi M, Collet M, Gayat E, Degos V, Duranteau J, Gregoire C, Sharshar T, Naim G, Cortier D, Jost PH, Foucrier A, Bagate F, de Montmollin E, Papin G, Magalhaes E, Guidet B, Ben Hadj Salem O, Benghanem S, le Guennec L, Delpierre E, Legriel S, Megarbane B, Toumert K, Tran M, Geri G, Monchi M, Bodiguel E, Mariotte E, Demoule A, Zarka J, Diehl JL, Roux D, Barre E, Tanaka S, Osman D, Pasquier P, Lamara F, Crassard I, Boursin P, Ruckly S, Staiquly Q, Timsit JF, Woimant F; SPICE Investigators. One-Year Outcomes in Patients With Acute Stroke Requiring Mechanical Ventilation. Stroke. 2023 Sep;54(9):2328-2337. doi: 10.1161/STROKEAHA.123.042910. Epub 2023 Jul 27. PubMed 37497675 ↗
  • Sonneville R, Mazighi M, Bresson D, Crassard I, Crozier S, de Montmollin E, Degos V, Faugeras F, Gayat E, Josse L, Lamy C, Magalhaes E, Maldjian A, Ruckly S, Servan J, Vassel P, Vigue B, Timsit JF, Woimant F; SPICE investigators. Outcomes of Acute Stroke Patients Requiring Mechanical Ventilation: Study Protocol for the SPICE Multicenter Prospective Observational Study. Neurocrit Care. 2020 Apr;32(2):624-629. doi: 10.1007/s12028-019-00907-0. PubMed 32026446 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03335995
Lead sponsor
Institut National de la Santé Et de la Recherche Médicale, France
Responsible party
Sponsor
First posted
Nov 8, 2017
Start date
Oct 18, 2017
Primary completion
Nov 18, 2019
Completion
Nov 18, 2020
Last update
Oct 3, 2025

Study contacts

Jean-François TIMSIT
study director · U 1137

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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