Stroke Prognosis in Intensive CarE

Acute Stroke Patients Requiring Invasive Mechanical Ventilation Clinical Trial

— SPICE  

Official title:

Stroke Prognosis in Intensive CarE - The SPICE Registry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03335995
• Other study ID #: C17-16
• Status: Completed
• Start date: October 18, 2017
• Est. completion date: November 18, 2020

Study information

• Verified date: August 2021
• Source: Institut National de la Santé Et de la Recherche Médicale, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 364
• Est. completion date: November 18, 2020
• Est. primary completion date: November 18, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Stroke Patients Requiring Invasive Mechanical Ventilation
• Stroke

Locations

Country	Name	City	State
France	Bichat Hospital	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	One year