Non-Invasive Detection of Aspergillosis in Ventilated Patients: Galactomannan Analysis in Exhaled Breath
Conditions: Bronchoalveolar Lavage Fluid, Sensitivity and Specificity, Critical Illness, Respiration Failure, Respiratory Fungal Infection, Exhaled Breath Condensate, Aspergillosis, Invasive Pulmonary
Sponsor: Lin Chen

Official Title: Non-Invasive Detection of Aspergillosis in 
Ventilated Patients: Galactomannan Analysis in Exhaled 
Breath Condensate 
 
Short Title: Aspergillosis Detection via EBC-GM in Ventilated Patients 
 
NCT Number: Pending 
 
 
Study Duration: January 2, 2023 - January 10, 2024 
 
Funding Source: Sichuan Provincial People's Hospital 
 
Principal Investigator: Dr. Lin Chen 
 
Affiliation: Sichuan Provincial People's Hospital 
Address: 32# W. Sec 2, 1st Ring Rd., Chengdu, Sichuan, China 
 
Contact Information: 
Email: chenlinhx@med.uestc.edu.cn 
Phone: +86 18111585286 
 
Document Date: April 12, 2023 
 
 
 
 

Study Protocol 
Title: Non-Invasive Detection of Aspergillosis in Ventilated Patients: A Study on the Diagnostic Utility 
of Galactomannan Analysis in Exhaled Breath Condensate 
Objective: Evaluate the effectiveness of measuring galactomannan (GM) levels in exhaled breath 
condensate (EBC) as a non-invasive method for diagnosing Invasive Aspergillosis Pneumonia (IPA) in 
mechanically ventilated patients. 
Background: Given the high mortality rates associated with IPA in critically ill patients, timely and 
accurate diagnosis is paramount. Traditional methods, such as the analysis of bronchoalveolar lavage 
fluid (BALF), while effective, are invasive and pose risks to patients. This study explores the potential 
of EBC as a safer alternative. 
Methodology: 
• 
Study Design: Comparative analysis of GM levels in EBC and BALF from both a rat model 
and mechanically ventilated IPA patients. 
• 
Participants: 75 mechanically ventilated patients suspected of IPA, with informed consent 
obtained. 
• 
Procedures: 
• 
Use of a novel EBC collection device for sample gathering. 
• 
Comparison of GM levels in EBC and BALF, alongside cytokine profiles. 
• 
Ethics Approval: Granted by the Medical Ethics Committee of Sichuan Provincial People's 
Hospital. 
Statistical Analysis Plan 
Data Analysis Strategy: 
1. Descriptive Statistics: 
• 
Summarize participant characteristics using means and standard deviations for 
continuous variables and frequencies for categorical variables. 
2. Diagnostic Marker Evaluation: 
• 
Perform logistic regression to evaluate the diagnostic utility of GM levels in EBC and 
BALF. 
• 
Receiver Operating Characteristic (ROC) curve analysis to determine the diagnostic 
effectiveness, identifying optimal cutoff values for sensitivity and specificity. 
3. Comparison Between Groups: 
• 
Use t-tests or Mann-Whitney U tests for continuous variables and chi-square tests for 
categorical variables to compare the IPA and control groups across different measures 
(e.g., GM levels, cytokine profiles). 
4. Correlation Analysis: 
• 
Assess the relationship between EBC-GM and BALF-GM levels using Pearson's or 
Spearman's correlation coefficients, depending on data distribution. 
5. Threshold Analysis: 
• 
Determine a specific cutoff value for EBC-GM that maximizes diagnostic accuracy, 
focusing on sensitivity, specificity, and the Area Under the Curve (AUC) from ROC 
analysis. 
Software: Statistical analysis will be conducted using SPSS version 25.0 or a similar statistical package. 
Ethical Considerations: Data will be anonymized to protect patient confidentiality, with all procedures 
carried out in accordance with the Declaration of Helsinki.