MedTrace Logo

Aspergillosis Detection Via EBC-GM in Ventilated Patients

NCT06333379 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 75

Last updated 2024-03-27

No results posted yet for this study

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.

Conditions

  • Bronchoalveolar Lavage Fluid
  • Sensitivity and Specificity
  • Critical Illness
  • Respiration Failure
  • Respiratory Fungal Infection
  • Exhaled Breath Condensate
  • Aspergillosis, Invasive Pulmonary

Interventions

OTHER

Compare the levels of Galactomannan (GM) levels in exhaled breath condensate (EBC) and BALF

Investigators tested EBC-GM levels and BALF-GM levels in patients with confirmed IPA to compare the diagnostic value of EBC-GM versus BALF-GM.

Sponsors & Collaborators

  • Lin Chen

    lead OTHER

Principal Investigators

  • Lin Chen, doctoral · Sichuan Provincial People's Hospita

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-02
Primary Completion
2023-12-30
Completion
2024-01-10

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06333379 on ClinicalTrials.gov