Effect of a Bundle of Interventions on the Outcomes of Patients With Intracranial Devices (ICP Monitor e EVD)
- Conditions
- Central Nervous System Infections
- Interventions
- Behavioral: Health care practices and routines
- Registration Number
- NCT06412549
- Lead Sponsor
- Beneficência Portuguesa de São Paulo
- Brief 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.
- Detailed Description
IMPACTO MR is a research platform that originated as a prospective and collaborative observational study collecting clinical, microbiological, and cost data from patients admitted to Brazilian adult ICUs during the three-year periods 2018-2020 and 2021-2023. Data were collected from all adult patients admitted to the ICUs of at least 61 hospitals selected for the platform. This project aims to collect data from approximately 20 participating hospitals that perform neurosurgical procedures involving external ventricular drain catheter implantation and intracranial pressure monitoring, with the goal of establishing national data on the prevalence of these conditions.
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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 1300
- Adult patients with intracranial pressure monitoring catheters (intraventricular or intraparenchymal) and/or external ventricular drain.
- The patient can be included from the moment the catheter is implanted, without there being a minimum time for inclusion.
- Suspected or confirmed brain death.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Intervention Health care practices and routines 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
- Primary Outcome Measures
Name Time Method To evaluate the effect of the intervention bundle in ICUs on reducing central nervous system infections related to devices. 30 days after study inclusion To compare the incidence of device-related central nervous system infections at baseline and after the implementation of the intervention bundle. The percentage of suspected infection cases and those confirmed by ANVISA criteria will be compared at both study timepoints.
- Secondary Outcome Measures
Name Time Method Drug treatment during hospital stay 30 days after study inclusion To compare treatment practices for device-related central nervous system infections at baseline versus the group included after the intervention bundle. The outcome will be measured based on the antibiotic classes used to treat CNS infection, dose and time of use of antibiotics. The treatment data will be collected from the medical prescription during the hospital stay.
Cost of hospital admission in dollars, comparing patients with and without infection 30 days after study inclusion Compare costs associated with the duration of infection at baseline versus the group included after the intervention bundle. The outcome will be measured based on the demographic characteristics, Saps3, infection (yes or no), use of antibiotics and time of permanence on ICU.
Rankin scale 30 days, 6 months and 1 year after study inclusion Measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability.
The patient is classified as follows:
* No symptoms at all;
* No significant disability despite symptoms; able to carry out all usual duties and activities
* Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance
* Moderate disability; requiring some help, but able to walk without assistance
* Moderately severe disability; unable to walk and attend to bodily needs without assistance
* Severe disability; bedridden, incontinent and requiring constant nursing care and attention
* Dead
Compare rankin scale score before and after the intervention bundle.Risk factors 30 days after study inclusion To compare microbiological characteristics of device-related central nervous system infections, considering the prevalence of microorganisms (multi-resistant or not).
Diagnostic accuracy 30 days after study inclusion The difference between the percentages of suspected and confirmed infection cases at baseline will be evaluated, compared to the group included after the intervention bundle.
Death rate 30 days, 6 months and 1 year after study inclusion The outcome will be measured based on the vital status on the hospital discharge, follow-up in 30 days, 6 months and 1 year.
Microbiological profile identified in CSF culture results. 30 days after study inclusion Microbiological characteristics of device-related central nervous system infections, considering the prevalence of microorganisms (multi-resistant or not) at baseline versus the group included after the intervention bundle. The outcome will be measured based on the positive liquor culture and antibiogram.
Adherence of the study site to the intervention bundle Monthly From the first patient enrollment at participating centers to the last hospital discharge of the recruited sample.