Stroke Prognosis in Intensive CarE (SPICE)

September 29, 2025 updated by: Institut National de la Santé Et de la Recherche Médicale, France

Stroke Prognosis in Intensive CarE - The SPICE Registry

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).

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

364

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75018
        • Bichat Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

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.

Description

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:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional outcome
Time Frame: One year
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).
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut National de la Santé Et de la Recherche Médicale, France

Investigators

  • Study Director: Jean-François TIMSIT, U 1137

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 18, 2017

Primary Completion (Actual)

November 18, 2019

Study Completion (Actual)

November 18, 2020

Study Registration Dates

First Submitted

October 19, 2017

First Submitted That Met QC Criteria

November 7, 2017

First Posted (Actual)

November 8, 2017

Study Record Updates

Last Update Posted (Estimated)

October 3, 2025

Last Update Submitted That Met QC Criteria

September 29, 2025

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C17-16

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Acute Stroke Patients Requiring Invasive Mechanical Ventilation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Denmark

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe