Effect of a Bundle of Interventions on the Outcomes of Patients With Intracranial Devices (ICP Monitor e EVD)
NCT ID: NCT06412549
Last Updated: 2024-05-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
1300 participants
INTERVENTIONAL
2024-06-01
2026-12-31
Brief Summary
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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.
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Detailed Description
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The first phase of the study will involve completing data collection for the prospective cohort conducted between 2022 and 2023. This cohort is part of the IMPACTO MR: Device-related central nervous system infections in adult intensive care units in Brazil - Action Plan Support Project Platform National Prevention and Control of Antimicrobial Resistance) with the same hospitals. This will represent the baseline incidence of central nervous system infections related to devices and care practices for patients with intracranial pressure monitoring catheters and external ventricular drains. The data will include information on risk factors, care processes, and clinical management in suspected central nervous system infections related to these devices.
In the second phase of the study, an intervention bundle will be implemented to prevent infections and improve care processes in these ICUs progressively. Diagnostic site visits will be conducted at hospitals to support the construction of this intervention bundle, and all participating hospitals will receive continuous training to facilitate measurement of results.
The intervention bundle will be based on ANVISA recommendations for controlling healthcare-associated infections. Currently, the recommendations are based on the care to be followed from pre-operative to post-operative stages, including the use of checklists with daily goals, recommendations for dressing care, catheter handling, and treatment in the presence of infection.
The intervention bundle will be developed by a minimum team of doctors and nurses from the coordinating hospital. After conducting a situational diagnosis, this team will develop care protocols, checklists with daily goals, and training materials for the participating centers.
Throughout the project, systematic feedback meetings will be held to monitor action plans, both remotely and, if necessary, in person.
The intervention will be implemented within each hospital until the proposed sample size is attained.
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
SUPPORTIVE_CARE
NONE
Study Groups
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Baseline
Participants over 18 years of age admitted to the ICU in the selected hospitals during the study period, using intracranial pressure monitoring catheters and/or external ventricular drain. Baseline database obtained from the study "Device-related Central Nervous System Infections in Adult Intensive Care Units in Brazil (IMPACTO-SNC)", Carried out during the period from 2022 to 2023.
No interventions assigned to this group
Intervention
Participants over 18 years old admitted to the ICU in the selected hospitals and trained in the intervention bundle during the study period, using intracranial pressure monitoring catheters and/or external ventricular shunt. Participants included in the period from 2024 to 2026
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* The patient can be included from the moment the catheter is implanted, without there being a minimum time for inclusion.
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Ministry of Health, Brazil
OTHER_GOV
Beneficência Portuguesa de São Paulo
OTHER
Responsible Party
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Viviane Cordeiro Veiga, MD, PhD
Principal Investigator
Principal Investigators
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Viviane Veiga, Phd
Role: PRINCIPAL_INVESTIGATOR
BP - A Beneficência Portuguesa de São Paulo
Renata Oliveira
Role: PRINCIPAL_INVESTIGATOR
Hospital Geral Clériston Andrade
Cássia Shinotsuka
Role: PRINCIPAL_INVESTIGATOR
Instituto Estadual do Cérebro Paulo Niemeyer
Thiago Lisboa
Role: PRINCIPAL_INVESTIGATOR
Hospital de Clinicas de Porto Alegre
Luciana Sanches
Role: PRINCIPAL_INVESTIGATOR
Hospital do Amor de Barretos
Lívia Medeiros
Role: PRINCIPAL_INVESTIGATOR
Hospital Pelópidas Silveira
Tássio Lavor
Role: PRINCIPAL_INVESTIGATOR
Hospital Getúlio Vargas
Débora Pinho
Role: PRINCIPAL_INVESTIGATOR
Hospital da Restauração
Cristiano Franke
Role: PRINCIPAL_INVESTIGATOR
Hospital de Pronto Socorro de Porto Alegre
Gabriela Teixeira
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitário Cajuru
Eliane Silva
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitário Onofre Lopes
Marcelo Romano
Role: PRINCIPAL_INVESTIGATOR
Hcor - Associação Beneficente Síria
Wilson Lovato
Role: PRINCIPAL_INVESTIGATOR
Hospital das Clínicas de Ribeirão Preto
Israel Maia
Role: PRINCIPAL_INVESTIGATOR
Instituto Baía Sul de Ensino e Pesquisa Irineu May Brodbeck
Priscila Gonçalves
Role: PRINCIPAL_INVESTIGATOR
Santa Casa de Misericordia de Passos
Flávia Machado
Role: PRINCIPAL_INVESTIGATOR
Hospital São Paulo
Glécia Rocha
Role: PRINCIPAL_INVESTIGATOR
Instituto Hospital de Base do Distrito Federal - IGESDF
Roberta Roepek
Role: PRINCIPAL_INVESTIGATOR
Hospital das Clínicas FMUSP
Central Contacts
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References
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Champey J, Mourey C, Francony G, Pavese P, Gay E, Gergele L, Manet R, Velly L, Bruder N, Payen JF. Strategies to reduce external ventricular drain-related infections: a multicenter retrospective study. J Neurosurg. 2018 Jun 22;130(6):2034-2039. doi: 10.3171/2018.1.JNS172486. Print 2019 Jun 1.
Ramanan M, Lipman J, Shorr A, Shankar A. A meta-analysis of ventriculostomy-associated cerebrospinal fluid infections. BMC Infect Dis. 2015 Jan 8;15:3. doi: 10.1186/s12879-014-0712-z.
Jin J, Akau Ola S, Yip CH, Nthumba P, Ameh EA, de Jonge S, Mehes M, Waiqanabete HI, Henry J, Hill A; International Society of Surgery (ISS) and the G4 Alliance International Standards and Guidelines for Quality Safe Surgery and Anesthesia (ISG-QSSA) Group. The Impact of Quality Improvement Interventions in Improving Surgical Infections and Mortality in Low and Middle-Income Countries: A Systematic Review and Meta-Analysis. World J Surg. 2021 Oct;45(10):2993-3006. doi: 10.1007/s00268-021-06208-y. Epub 2021 Jul 3.
Lord AS, Nicholson J, Lewis A. Infection Prevention in the Neurointensive Care Unit: A Systematic Review. Neurocrit Care. 2019 Aug;31(1):196-210. doi: 10.1007/s12028-018-0568-y.
Karvouniaris M, Brotis A, Tsiakos K, Palli E, Koulenti D. Current Perspectives on the Diagnosis and Management of Healthcare-Associated Ventriculitis and Meningitis. Infect Drug Resist. 2022 Feb 28;15:697-721. doi: 10.2147/IDR.S326456. eCollection 2022.
Other Identifiers
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6. NUP25000.1672362023-51
Identifier Type: -
Identifier Source: org_study_id
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