Aspergillosis Detection Via EBC-GM in Ventilated Patients : Non-Invasive Detection of Aspergillosis in Ventilated Patients: Galactomannan Analysis in Exhaled Breath

Research Proposal: Advancing the Diagnosis of Invasive Pulmonary Aspergillosis through Exhaled Breath Condensate Analysis in Ventilated Patients Background: Invasive Pulmonary Aspergillosis (IPA) remains a formidable challenge in the management of critically ill, immunocompromised patients, especially those requiring mechanical ventilation in Intensive Care Units (ICUs). The high morbidity and mortality rates associated with IPA underscore the urgent need for early and accurate diagnostic methods. Traditional diagnostic approaches, though effective, are invasive and pose significant risks to already vulnerable patients. This study introduces a novel, non-invasive diagnostic methodology by measuring galactomannan (GM) levels in Exhaled Breath Condensate (EBC), potentially revolutionizing the early detection of IPA.Objective: To evaluate the effectiveness of a non-invasive diagnostic approach by analyzing galactomannan levels in exhaled breath condensate (EBC) for detecting Invasive Pulmonary Aspergillosis (IPA) in mechanically ventilated ICU patients.Methods:Study Design: A prospective clinical trial involving 75 mechanically ventilated patients suspected of having IPA within the Medical Intensive Care Unit (MICU) of a tertiary hospital.Data Collection: Utilizing a self-designed EBC collection device, EBC samples will be collected from participants and analyzed for GM levels. These will be compared to Bronchoalveolar Lavage Fluid (BALF) GM levels, considered the current gold standard in IPA diagnostics.Analytical Approach: The study will focus on assessing the diagnostic accuracy of EBC-GM measurements by determining sensitivity, specificity, and overall concordance with BALF-GM levels. The potential enhancement of diagnostic precision with the inclusion of cytokine measurements will also be explored.Innovation: By leveraging a cutting-edge EBC collection device, this research aims to bypass the complications associated with invasive diagnostic procedures, offering a safer, more patient-friendly alternative. This innovative approach has the potential to significantly impact clinical practices in ICU settings by facilitating early and accurate IPA diagnosis without the need for bronchoscopy.Expected Outcomes:Diagnostic Performance: Investigators anticipate demonstrating that EBC-GM levels provide a reliable, non-invasive marker for IPA, with diagnostic accuracy comparable to BALF-GM measurements.Clinical Impact: The successful validation of EBC-GM as a diagnostic tool for IPA will offer a significant advancement in the management of critically ill patients, reducing the need for invasive procedures and associated risks.Guideline Integration: Findings from this study are expected to support the integration of EBC-GM analysis into clinical guidelines as a recommended diagnostic approach for IPA in mechanically ventilated patients.Significance: This research has the potential to transform IPA diagnostics in ICU settings, promoting a shift towards non-invasive, risk-free methods that can lead to earlier detection and improved patient outcomes. By minimizing invasive diagnostic interventions, the study aims to enhance the safety and efficacy of IPA management in critically ill populations.Ethics and Dissemination: The study adheres to the highest ethical standards, with approval from the institutional review board ensuring the protection and well-being of participants. Results will be actively disseminated through peer-reviewed journals and conference presentations, contributing to global efforts in improving ICU patient care in the context of fungal infections..

Medienart:	Klinische Studie

Erscheinungsjahr:	2024
Erschienen:	2024

Enthalten in:	ClinicalTrials.gov - (2024) vom: 27. März Zur Gesamtaufnahme - year:2024

Sprache:	Englisch

Links:	Volltext [kostenfrei]

Themen:	610 Aspergillosis Critical Illness Invasive Pulmonary Aspergillosis Mycoses Recruitment Status: Completed Respiratory Insufficiency Study Type: Observational

Anmerkungen:	Source: Link to the current ClinicalTrials.gov record., First posted: March 27, 2024, Last downloaded: ClinicalTrials.gov processed this data on April 03, 2024, Last updated: April 03, 2024

Study ID:	NCT06333379 SichuanPPHLC04 2020LY01
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PPN (Katalog-ID):	CTG000189898