protocolSection identificationModule nctId: NCT06333379, orgStudyIdInfo id: SichuanPPHLC04, secondaryIdInfos id: 2020LY01, type: OTHER_GRANT, domain: Sichuan Provincial People's Hospital, briefTitle: Aspergillosis Detection Via EBC-GM in Ventilated Patients, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-01-02, primaryCompletionDateStruct date: 2023-12-30, completionDateStruct date: 2024-01-10, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Lin Chen, class: OTHER, descriptionModule briefSummary: Brief Research Proposal: Non-Invasive Detection of Invasive Pulmonary Aspergillosis in ICU Patients Background: Invasive Pulmonary Aspergillosis (IPA) is a critical threat to patients in ICUs, especially those undergoing mechanical ventilation. Traditional diagnostic methods are invasive and carry risks. This study proposes a non-invasive, innovative approach utilizing galactomannan (GM) analysis in Exhaled Breath Condensate (EBC) for early IPA detection.Objective: To evaluate the diagnostic accuracy of measuring GM levels in EBC for detecting IPA in mechanically ventilated patients, comparing it against the conventional Bronchoalveolar Lavage Fluid (BALF)-GM measurements.Methods: A clinical trial will be conducted with 75 mechanically ventilated patients suspected of having IPA. The study will compare the effectiveness of EBC-GM levels against BALF-GM levels in diagnosing IPA, focusing on sensitivity, specificity, and diagnostic accuracy. The novel, self-designed EBC collection device will facilitate the safe and efficient collection of EBC from patients.Expected Outcomes:Validation of EBC-GM Diagnostic Accuracy: Anticipate demonstrating that EBC-GM levels provide a comparable diagnostic accuracy to BALF-GM, establishing a non-invasive, safer alternative for IPA detection.Implementation of a Non-Invasive Diagnostic Tool: The study aims to introduce a non-invasive diagnostic approach that can potentially replace more risky, invasive methods, improving patient care in ICUs.Contribution to Clinical Practice: By providing a new method for early and safer detection of IPA, the study is expected to influence clinical guidelines and practices in the management of critically ill, ventilated patients.Significance: This research has the potential to revolutionize the diagnosis of fungal infections in critically ill patients by offering a non-invasive, accurate, and safer diagnostic tool, thereby improving patient outcomes and reducing the risks associated with invasive diagnostic procedures., conditionsModule conditions: Bronchoalveolar Lavage Fluid, conditions: Sensitivity and Specificity, conditions: Critical Illness, conditions: Respiration Failure, conditions: Respiratory Fungal Infection, conditions: Exhaled Breath Condensate, conditions: Aspergillosis, Invasive Pulmonary, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 75, type: ACTUAL, armsInterventionsModule interventions name: Compare the levels of Galactomannan (GM) levels in exhaled breath condensate (EBC) and BALF, outcomesModule primaryOutcomes measure: Diagnostic accuracy of EBC-GM vs. BALF-GM, primaryOutcomes measure: EBC-GM levels:, secondaryOutcomes measure: Correlation between EBC-GM and BALF-GM levels, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sichuan Provincial People's Hospital, city: Chengdu, state: Sichuan, zip: 86610072, country: China, geoPoint lat: 30.66667, lon: 104.06667, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2023-04-12, uploadDate: 2024-03-22T15:01, filename: Prot_SAP_000.pdf, size: 81579, largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2023-04-12, uploadDate: 2024-03-22T15:02, filename: ICF_001.pdf, size: 133154, hasResults: False