Assessment of an Exhaled Breath Test Using High-Pressure Photon Ionization Time-of-Flight Mass Spectrometry to Detect Bronchiectasis
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Bronchiectasis
- Sponsor
- Shanghai Pulmonary Hospital, Shanghai, China
- Enrollment
- 544
- Locations
- 1
- Primary Endpoint
- The Ability of the Breath Test Model to Distinguish Bronchiectasis From Healthy People
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
To investigate whether the breath test is able to detect bronchiectasis using breathomics. This study was conducted with a prospective specimen collection, evaluator-blinded, case-controlled clinical study designed to evaluate the accuracy of breathomics to diagnosis of bronchiectasis in adults.
Detailed Description
Bronchiectasis is a chronic airway inflammation with irreversible expansion of bronchial walls, which is characteristic by chronic cough, mucinous sputum, dyspnea and wheezing. High resolution CT (HRCT) combined with clinical manifestations is the main diagnostic method of bronchiectasis, but HRCT is expensive and radioactive. Therefore, it is urgent to develop a new technology to diagnose bronchiectasis. Exhaled breath may be a better tool for bronchiectasis detection because of its noninvasive nature. Many efforts have been made to develop breath tests for lung cancer, asthma and Helicobacter pylori infection. However, little studies pay attention to bronchiectasis. High-pressure photon ionization time-of-flight mass spectrometry (HPPI-TOFMS) is a promising tool for breath testing, because it is highly sensitive, does not require pretreatment of exhaled breath, and holds great tolerance for humidity. In our case-control diagnostic study, we investigated whether a breath test combining HPPI-TOFMS and a support vector machine (SVM) algorithm was able to distinguish patients with bronchiectasis from control individuals.
Investigators
Jin-Fu Xu
Chief of Respiratory and Critical Care Medicine
Shanghai Pulmonary Hospital, Shanghai, China
Eligibility Criteria
Inclusion Criteria
- •BE Patients were recruited according to the following inclusion criteria: (1) Age\>18 years; (2) the diagnosis of BE was according to European Respiratory Society guidelines for the management of adult bronchiectasis; (3) Willing to join in and sign the informed consent form.
- •Healthy control subjects were recruited according to the following inclusion criteria:(1) Age\>18 years; (2) No history of any lung disease (according to pulmonary imaging and physical examinations); (3) Willing to join in and sign the informed consent form.
- •Unhealthy control subjects were recruited according to the following inclusion criteria: (1) Age\>18 years; (2) The diagnosis of ILD was according to HRCT and clinical symptoms by two experts' consensus; (3) The diagnosis of Sarcoidosis (SA) was according to American Thoracic Society Clinical Practice Guideline;(4) Willing to join in and sign the informed consent form.
Exclusion Criteria
- •(1) Patients combined with serious comorbidities (chronic renal failure, hepatic disease, etc.); (2) Patients who are diagnosed with asthma, pneumonia, malignant tumor, and COPD; (3) Women who are pregnant or preparing for pregnancy or breastfeeding; (4) Participated in other clinical trials within three months; (5) Refused to join in and sign the informed consent form.
Outcomes
Primary Outcomes
The Ability of the Breath Test Model to Distinguish Bronchiectasis From Healthy People
Time Frame: One week.Exhaled breath samples were collected on the first day of patients' hospitalization and sent to detect VOCs.The entire process will take one week.
Evaluate the ability of the breath test model to distinguish bronchiectasis from healthy individuals by measuring the area under the receiver operating characteristic (ROC) curves. The maximum value in the area below the receiver is 1. The closer the value is to 1, the higher the prediction accuracy of the model.
Secondary Outcomes
- The Sensitivity of the Breath Test Model to Distinguish Bronchiectasis From Healthy People(One week.Exhaled breath samples were collected on the first day of patients' hospitalization and sent to detect VOCs.The entire process will take one week.)