Non-Invasive Detection of Aspergillosis in Ventilated Patients: Galactomannan Analysis in Exhaled Breath
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- EBC-GM levels:
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: Between 18 and 85 years old. Antifungal Medication Use: Participants who have not used any antifungal medications within the three months prior to enrollment.
- •Mechanical Ventilation Status: Patients who have been undergoing mechanical ventilation treatment for more than three days.
排除标准
- •Inadequate Clinical Data: Inability to provide reliable diagnostic measurements or insufficient clinical information.
- •Early Mortality: Patients who die within the first three days of ICU (Intensive Care Unit) admission or during the initial phase of the study.
- •Pregnancy: To avoid potential confounding effects on immune function and the composition of EBC (Exhaled Breath Condensate), pregnant women are excluded.
结局指标
主要结局
EBC-GM levels:
时间窗: The stability of the patients' vital signs was observed within 72 hours to assess the diagnostic accuracy of EBC-GM and BALF-GM.
Evaluate sensitivity and specificity in differentiating patients with IPA from mechanically ventilated patients with non-aspergillosis infections, and determining the critical value of EBC-GM in the diagnosis of IPA.
Diagnostic accuracy of EBC-GM vs. BALF-GM
时间窗: EBC and BALF samples were collected simultaneously on the day of patient admission.
The diagnostic accuracy of Galactomannan (EBC-GM) levels in Exhaled Breath Condensate vs. Bronchoalveolar Lavage Fluid (BALF-GM) levels was measured by Receiver Operating Characteristic (ROC) area under the curve (AUC) assessment. Accuracy of Galactomannan (BALF-GM) levels in the diagnosis of Invasive Pulmonary Aspergillosis (IPA).
次要结局
- Correlation between EBC-GM and BALF-GM levels(Based on samples collected on the same day, followed by 72 hours of observation.)
研究者
Lin Chen
chief physician
Sichuan Provincial People's Hospital