Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06412549
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-14
First Post:
2024-04-16
Brief Title:
Effect of a Bundle of Interventions on the Outcomes of Patients With Intracranial Devices ICP Monitor e EVD
Sponsor:
Beneficência Portuguesa de São Paulo
Organization:
Beneficência Portuguesa de São Paulo
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None