Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06333379
Status:
COMPLETED
Last Update Posted:
2024-03-27
First Post:
2024-03-18
Brief Title:
Aspergillosis Detection Via EBC-GM in Ventilated Patients
Sponsor:
Lin Chen
Organization:
Sichuan Provincial Peoples Hospital
Study Overview
Official Title:
Non-Invasive Detection of Aspergillosis in Ventilated Patients Galactomannan Analysis in Exhaled Breath
Status:
COMPLETED
Status Verified Date:
2024-03
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:
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
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
Detailed Description:
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
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
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2020LY01 | OTHER_GRANT | Sichuan Provincial Peoples Hospital | None |