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NCT05501613 Clinical Trial

Early Multimodal Neuromonitoring For Spontaneous Intracerebral Hemorrhage (ICH)

Critically Ill Clinical Trial

Official title:
Early Multimodal Neuromonitoring Parameters as Prognostic Factors For Critically Ill Spontaneous ICH Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05501613
Other study ID # 202201
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 2015
Est. completion date February 1, 2023

Study information
Verified date February 2023
Source Universidade do Porto
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The investigators intend to assess the predictive value of early (first 48 hours) multimodal neuromonitoring parameters concerning late survival in critically ill intracerebral hemorrhage (ICH) patients.

Description:

Retrospective observational study based on analyzing the first 48 hours of the multimodal neuromonitoring signal, from spontaneous ICH patients, whose treatment includes invasive intraparenchymal neuromonitoring, treated from January 2015 to September 2021 in a tertiary hospital.

Recruitment information / eligibility
Status Completed
Enrollment 65
Est. completion date February 1, 2023
Est. primary completion date October 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Spontaneous Intracerebral Hemorrhage - ICU admission - Need of Sedation and Ventilatory Support - Need of Intracerebral Neuromonitoring Exclusion Criteria: - Etiology for Intracerebral hemorrhage such as tumor, vascular malformation, ischemic transformation.

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Multimodal Neuromonitoring
Invasive Multimodal Neuromonitoring

Locations
Country Name City State
Portugal Centro Hospitalar Universitário de São João Porto

Sponsors (1)
Lead Sponsor Collaborator
Universidade do Porto

Country where clinical trial is conducted

Portugal, 

Outcome
Type Measure Description Time frame Safety issue
Primary Survival 1 and 6 months survival 1 and 6 months
Primary Functional Outcome 6 month functional outcome with Modified Rankin Scale - 0 (No symptoms); 1 (No significant disability); 2 (Slight disability); 3 (Moderate disability); 4 (Moderately Severe Disability); 5 (Severe Disability); 6 (Dead). 6 month
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