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NOT YET RECRUITING
NCT06412549
NA

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

Sponsor: Beneficência Portuguesa de São Paulo

View on ClinicalTrials.gov

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.

Official title: IMPACTO MR: Effect of a Bundle of Interventions on Patients With Central Nervous System Devices - Project Platform Supporting the National Action Plan for Prevention and Control of Antimicrobial Resistance

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1300

Start Date

2024-06-01

Completion Date

2026-12-31

Last Updated

2024-05-14

Healthy Volunteers

No

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.