Effect of a Bundle of Interventions on the Outcomes of Patients With Intracranial Devices (ICP Monitor e EVD)

Summary

Non-randomized clinical trial conducted in the adult ICUs of Brazilian hospitals participating in the IMPACTO MR Platform, involving adult patients using an intracranial pressure monitoring catheter device or external ventricular drain.

The study will test the hypothesis that the intervention bundle, following ANVISA recommendations for care practices, will reduce the rates of central nervous system infections associated with ICP and EVD devices.

This reduction is expected to lead to more accurate diagnoses, decreased antibiotic usage, shortened ICU and hospital stays, and reduced hospital costs.

Conditions

• Central Nervous System Infections

Interventions

BEHAVIORAL

Health care practices and routines

The scope of the project includes a diagnostic visit to participating hospitals, conducted by the coordinating center team, to understand existing protocols related to the management of invasive central nervous system devices (such as intracranial pressure monitoring catheters or external ventricular drains), as well as the physical infrastructure, human resources, and other precautions taken for the prevention and treatment of central nervous system infections. All recommendations in the intervention bundle for patient care will align with the guidelines of the National Health Surveillance Agency (ANVISA) and the best available scientific evidence for preventing infections associated with central nervous system devices. * Provide the best care for patients with ICP and/or EVD, based on the best available evidence, with regard to the insertion and maintenance of catheters, as well as diagnosis and treatment in the presence of infection. * Training of the multidisciplinary team.

Sponsors & Collaborators

• Ministry of Health, Brazil

  collaborator OTHER_GOV

• Beneficência Portuguesa de São Paulo

  lead OTHER

Principal Investigators

• Viviane Veiga, Phd · BP - A Beneficência Portuguesa de São Paulo

• Renata Oliveira · Hospital Geral Clériston Andrade

• Cássia Shinotsuka · Instituto Estadual do Cérebro Paulo Niemeyer

• Thiago Lisboa · Hospital de Clinicas de Porto Alegre

• Luciana Sanches · Hospital do Amor de Barretos

• Lívia Medeiros · Hospital Pelópidas Silveira

• Tássio Lavor · Hospital Getúlio Vargas

• Débora Pinho · Hospital da Restauração

• Cristiano Franke · Hospital de Pronto Socorro de Porto Alegre

• Gabriela Teixeira · Hospital Universitário Cajuru

• Eliane Silva · Hospital Universitário Onofre Lopes

• Marcelo Romano · Hcor - Associação Beneficente Síria

• Wilson Lovato · Hospital das Clínicas de Ribeirão Preto

• Israel Maia · Instituto Baía Sul de Ensino e Pesquisa Irineu May Brodbeck

• Priscila Gonçalves · Santa Casa de Misericordia de Passos

• Flávia Machado · Hospital São Paulo

• Glécia Rocha · Instituto Hospital de Base do Distrito Federal - IGESDF

• Roberta Roepek · Hospital das Clínicas FMUSP

Study Design

Allocation

NON_RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-06-01

Primary Completion

2026-10-01

Completion

2026-12-31