Deep Learning Diagnostic and Risk-stratification for Idiopathic Pulmonary Fibrosis and Chronic Obstructive Pulmonary Disease in Digital Lung Auscultations
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Predictive performance of the DeepBreath algorithm to stratify ILD severity based on human digital lung sounds recordings and LUS (i.e. physiological parameters) compared to grading scales.
研究概览
简要总结
Idiopathic pulmonary fibrosis (IPF), non-specific interstitial pneumonia (NSIP), and chronic obstructive pulmonary disease (COPD) are severe, progressive, irreversibly incapacitating pulmonary disorders with modest response to therapeutic interventions and poor prognosis. Prompt and accurate diagnosis is important to enable patients to receive appropriate care at the earliest possible stage to delay disease progression and prolong survival.
Artificial intelligence (AI)-assisted digital lung auscultation could constitute an alternative to conventional subjective operator-related auscultation to accurately and earlier diagnose these diseases. Moreover, lung ultrasound (LUS), a relevant gold standard for lung pathology, could also benefit from automation by deep learning.
详细描述
Aim: To develop and determine the predictive power of an AI (deep learning) algorithm in identifying the acoustic and LUS signatures of IPF, NSIP and COPD in an adult population and discriminating them from age-matched, never smoker, control subjects with normal lung function.
Methodology: A single-center, prospective, population-based case-control study that will be carried out in subjects with IPF, NSIP and COPD. A total of 120 consecutive patients aged ≥ 18 years and meeting IPF, NSIP or COPD international criteria, and 40 age-matched controls, will be recruited in a Swiss pulmonology outpatient clinic with a total of approximately 7000 specialized consultations per year, starting from August 2022.
At inclusion, demographic and clinical data will be collected. Additionally, lung auscultation will be recorded with a digital stethoscope and LUS performed. A deep learning algorithm (DeepBreath) using various deep learning networks with aggregation strategies will be trained on these audio recordings and lung images to derive an automated prediction of diagnostic (i.e., positive vs negative) and risk stratification categories (mild to severe).
Secondary outcomes will be to measures the association of analysed lung sounds with clinical, functional and radiological characteristics of IPF, NSIP and COPD diagnosis. Patients' quality of life will be measured with the standardized dedicated King's Brief Interstitial Lung Disease (K-BILD) and the COPD assessment test (CAT) questionnaires.
Expected results: This study seeks to explore the synergistic value of several point-of-care-tests for the detection and differential diagnosis of ILD and COPD as well as estimate severity to better guide care management in adults
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent
- •age > 18 years old.
- •patients with already-diagnosed IPF (group 1) prior to the consultation (index) date.
- •patients with already-diagnosed NSIP (group 2) prior to the consultation (index) date.
- •patients with already-diagnosed COPD (group 3) prior to the consultation (index) date.
- •Control subjects must be followed-up at the pulmonology outpatient clinic for:
- •obstructive sleep apnoea.
- •occupational lung diseases (miners, chemical workers, etc.).
- •pulmonary nodules (considered benign after 2 years).
排除标准
- •patients who cannot be mobilized for posterior auscultation.
- •patients known for severe cardiovascular disease with pulmonary repercussion.
- •patients known for a concurrent, acute, infectious pulmonary disease (e.g., pneumonia, bronchitis).
- •patients known for asthma.
- •patients known or suspected of immunodeficiency, alpha-1-antitrypsin deficit, and or under immunotherapy.
- •patients with physical inability to follow procedures.
- •patients with inability to give informed consent.
结局指标
主要结局
Predictive performance of the DeepBreath algorithm to stratify ILD severity based on human digital lung sounds recordings and LUS (i.e. physiological parameters) compared to grading scales.
时间窗: During lung auscultation (10 minutes). Each patient will provide 10 recordings of 30 seconds. LUS images and 5 second video clips of each anatomic region (10 regions represented).
To determine the ILD clinical severity predictive performance of the DeepBreath algorithm based on human digital lung sounds recordings and LUS, risk stratification will use multiclass or regression according to grading scales obtained from: * K-BILD and CAT impact of life questionnaire. * Lung function tests (Forced Expiratory Volume in 1 sec, Forced vital capacity, Forced Expiratory Volume in 1 sec/Forced vital capacity, Total lung capacity, functional respiratory capacity, Transfer capacity for carbon monoxide, Alveolar Volume). * High-Resolution Computed Tomography (severity markers that will be used are: traction bronchiectasis, presence of honeycombing, ground glass opacities, reticulation, emphysema. Chest CT-scans will be reviewed independently by two radiologists blinded to each other).
To differentiate ILD from control subjects based on digital lung sounds recordings and LUS.
时间窗: During lung auscultation (10 minutes). Each patient will provide 10 recordings of 30 seconds. LUS images and 5 second video clips of each anatomic region (10 regions represented).
To determine the predictive performance of the AI algorithm-evaluated lung auscultation and LUS in the identification and risk stratification of ILD signatures from control subjects described in terms of descriptive statistics, area under the receiver operating characteristic curve, sensitivity, specificity, positive and negative predictive values, and likelihood ratios (95% confidence intervals). Digital lung sounds will be transformed to Mel Frequency Cepstrum Coefficients. Several data augmentation techniques will be explored. The effect of each pre-processing method will be tested. The best performing approach according to sensitivity and specificity will be reported. This dataset will then be fed into a various deep learning networks with aggregation strategies for binary classification into positive vs negative for diagnostic results for: * ILD or control subjects * ILD or COPD * (If ILD+) IPF or NSIP The same prediction will also be made using LUS images.
Performance of the DeepBreath algorithm to subcategorize ILD by discriminating digital lung sounds recordings and LUS (i.e. physiological parameters).
时间窗: During lung auscultation (10 minutes). Each patient will provide 10 recordings of 30 seconds. LUS images and 5 second video clips of each anatomic region (10 regions represented).
The performance of the DeepBreath algorithm to determine the subcategories of ILD such as IPF and NSIP based on digital lungs sounds and LUS according to gold standard diagnosis: * IPF follows the Fleischner Society Consensus criteria. * NSIP diagnosis follows the American Thoracic Society classification.
次要结局
- To test whether performance of DeepBreath could be improved using clinical features (i.e., signs, respiratory symptoms, demographics, medical history and basic paraclinical tests).(During the data analysis period (i.e., after the 60-minute study intervention period))
- Diagnostic performance of DeepBreath to detect crackles in IPF patients.(During the data analysis period (i.e., after the 60-minute study intervention period).)
- K-BILD(Baseline)
- CAT(Baseline)
- Performance of human expert-identified acoustic signatures.(During the data analysis period (i.e., after the 60-minute study intervention period).)
- Agreement of human labels with objectively clustered pathological sounds by machine learning.(During the data analysis period (i.e., after the 60-minute study intervention period).)