Point-of-care Ultrasound for the Diagnosis and Risk Stratification of Lower Respiratory Tract Infections in TB Endemic Regions: a Multicenter Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 504
- 试验地点
- 3
- 主要终点
- Sensitivity of LUS for the detection of TB
研究概览
简要总结
In Sub-Saharan Africa, lower respiratory tract infections (LRTIs) and tuberculosis (TB) jointly are the leading cause of overall mortality. There is a need to integrate sustainable triage and management strategies into standard care. The TrUST study investigates the utility of point-of-care ultrasound (POCUS) for diagnosis and prognosis of LRTIs in TB endemic regions in the outpatient triage setting. Automated interpretation of POCUS by artificial intelligence (AI) may further standardize and improve its predictive utility as well as facilitate its implementation into usual practice.
详细描述
Design International multicentre prospective cohort study
Setting This study aims to explore the performance of POCUS in a pre-hospital setting in countries with different prevalences of HIV: South- Africa (high prevalence), Benin (low prevalence) and Mali (low prevalence).
Study procedures Pre-recruitment training Before initiating the study, participating clinicians will benefit from lung ultrasound (LUS) and POCUS protocols for extra pulmonary TB (FASH+ exam) training with a field expert. The participating clinicians are required to pass a final expert test before start of patient recruitment and to have a minimum of 20 supervised US.
Inclusion (Day 0) Patients inclusion will be performed over a period of 18 to maximum 24 months. Recruitment will stop before the anticipated end if the inclusion of 1000 patients is reached.
Clinical data Data collected include demographic characteristics (age, sex, occupation etc.), past medical history (previous TB, Coronavirus Disease (COVID), vaccination status, documented past episodes of COVID-19, HIV status,...), symptoms (respiratory symptoms, specific COVID-19 symptoms (from the Centers for Disease Control COVID checklist), specific pulmonary TB symptoms (from the CDC TB checklist) and routine clinical examination findings (vital parameters, oxygen saturation, lung auscultation,...).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Age ≥18 years
- •Suspicion of lower respiratory tract infection (defined as presence of cough with at least one of the following: fever, dyspnea/tachypnea, sputum production, chest pain, hemoptysis or cachexia)
排除标准
- •Cough/dyspnea from a definite non-infectious origin (cardiac, asthmatic...)
- •Inability to cooperate with ultrasound procedure
- •Inability to sign informed consent (third witness procedure available for illiterate patients)
结局指标
主要结局
Sensitivity of LUS for the detection of TB
时间窗: 18 to 24 months
For LUS, each lung quadrant will be scored using a 6 feature LUS score (modified Soldati score) ranging from 1 (aerated lung), 2 (interstitial syndrome), 3 (sub centimeter pleural lesions), 4 (lung consolidation), 5 (pleural effusion) to 6 (pneumothorax). Sensitivity of LUS score for the diagnosis of TB using microbiological tests (GenXpert MTB/RIF for HIV negative patients, mycobacterial culture for HIV patients and extra-pulmonary samples) as reference standards
Specificity of FASH PLUS for the detection of TB
时间窗: 24 to 36 months
For the pericardial and abdominal ultrasound, a score according to the FASH PLUS protocol will be attributed ranging from 0 (no pathology) to 6 (presence of pericardial effusion, abdominal adenopathies, pleural effusion, splenic lesions, hepatic lesions, ascites). Specificity of FASH PLUS score for the diagnosis of TB using microbiological tests (GenXpert MTB/RIF for HIV negative patients, mycobacterial culture for HIV patients and extra-pulmonary samples) as reference standards.
Specificity of AI-interpreted LUS for the detection of TB
时间窗: 24 to 36 months
LUS images will be scored binary by microbiological-label trained algorithms as TB or not TB. Prediction: Specificity of AI-assisted interpretation LUS for the detection of TB using microbiological tests as reference standards
Sensitivity of AI-interpreted FASH PLUS for the detection of TB
时间窗: 24 to 36 months
FASH PLUS images will be scored binary by microbiological-label trained algorithms as TB or not TB. Prediction: Sensitivity of FASH PLUS for the detection of TB using microbiological tests as reference standards
Sensitivity of combined LUS and FASH PLUS features for the detection of TB
时间窗: 24 to 36 months
Sensitivity of combined LUS and FASH PLUS score for the diagnosis of TB using microbiological tests (GenXpert MTB/RIF for HIV negative patients, mycobacterial culture for HIV patients and extra-pulmonary samples) as reference standards.
Specificity of combined LUS and FASH PLUS features for the detection of TB
时间窗: 24 to 36 months
Specificity of combined LUS and FASH PLUS score for the diagnosis of TB using microbiological tests (GenXpert MTB/RIF for HIV negative patients, mycobacterial culture for HIV patients and extra-pulmonary samples) as reference standards.
Specificity of AI-interpreted FASH PLUS for the detection of TB
时间窗: 24 to 36 months
FASH PLUS images will be scored binary by microbiological-label trained algorithms as TB or not TB. Prediction: Specificity of FASH PLUS for the detection of TB using microbiological tests as reference standards
Sensitivity of FASH PLUS for the detection of TB
时间窗: 24 to 36 months
For the pericardial and abdominal ultrasound, a score according to the FASH PLUS protocol will be attributed ranging from 0 (no pathology) to 6 (presence of pericardial effusion, abdominal adenopathies, pleural effusion, splenic lesions, hepatic lesions, ascites). Sensitivity of FASH PLUS score for the diagnosis of TB using microbiological tests (GenXpert MTB/RIF for HIV negative patients, mycobacterial culture for HIV patients and extra-pulmonary samples) as reference standards.
Specificity of LUS for the detection of TB
时间窗: 18 to 24 months
For LUS, each lung quadrant will be scored using a 6 feature LUS score (modified Soldati score) ranging from 1 (aerated lung), 2 (interstitial syndrome), 3 (sub centimeter pleural lesions), 4 (lung consolidation), 5 (pleural effusion) to 6 (pneumothorax). Sensitivity of LUS score for the diagnosis of TB using microbiological tests (GenXpert MTB/RIF for HIV negative patients, mycobacterial culture for HIV patients and extra-pulmonary samples) as reference standards
Sensitivity of AI-interpreted LUS for the detection of TB
时间窗: 24 to 36 months
LUS images will be scored binary by microbiological-label trained algorithms as TB or not TB. Prediction: Sensitivity of AI-assisted interpretation LUS for the detection of TB using microbiological tests as reference standards
次要结局
- Qualitative assessment using semi-structured interviews (based on grounded theory methods) with end users of the barriers and facilitators of the implementation of AI clinical decision support(12 months)
- Qualitative assessment using semi-structured interviews (based on grounded theory methods) with end users of the barriers and facilitators of the implementation of POCUS(12 months)
研究者
Dr Boillat-Blanco Noemie
Principal investigator
Centre Hospitalier Universitaire Vaudois