Hospital-acquired Pneumonia After Cardiovascular Surgery (CS): the Prediction and Assessment of Long-term Cardiovascular and Pulmonary Outcomes With Artificial Intelligence (AI) - (PNEUMONIA-CS-AI)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 700
- 试验地点
- 1
- 主要终点
- Hospital acquired pneumonia
研究概览
简要总结
This multicenter, prospective, observational study aims to address two primary objectives.
The first objective is to demonstrate that hospital-acquired pneumonia (nosocomial pneumonia) following cardiac surgery can be predicted using artificial intelligence (AI), and to develop a personalized risk calculator for its development.
The second objective is to demonstrate that hospital-acquired pneumonia can serve as a risk factor for a 1-year composite cardiovascular and pulmonary outcome after cardiac surgery, and to develop a personalized risk calculator for this composite outcome.
The composite outcome will include the occurrence of any of the following events:
- Respiratory death
- Hospitalization for respiratory diseases
- Development of oxygen dependence
- New-onset asthma, COPD, or interstitial lung disease
- Initiation or intensification of bronchodilator or corticosteroid therapy
- Cardiovascular death
- Acute myocardial infarction
- Unstable angina
- Myocardial revascularization
- Acute ischemic stroke
- Transient ischemic attack
- Acute heart failure
- Hospitalization for decompensated heart failure
- New-onset atrial fibrillation or ventricular tachycardia
- Initiation or intensification of antiarrhythmic therapy Both objectives will be addressed using artificial intelligence technologies applied during the data analysis phase.
This is a non-interventional study. Patient evaluation and treatment are conducted in strict accordance with approved standards of medical care for the respective conditions. No experimental or unregistered (not approved for use in the Russian Federation) medical or diagnostic procedures will be performed during this study.
详细描述
Hospital-acquired pneumonia (nosocomial pneumonia) is one of the most common complications following cardiac and/or vascular surgery, with an incidence reaching up to 37% after certain types of procedures. This complication is associated with prolonged hospital stays, increased healthcare costs, and higher mortality rates both during hospitalization and within 5 years post-surgery. To determine the necessity of implementing additional personalized preventive measures against pneumonia, it is clinically valuable to assess the probability of its development in each individual patient. A medical risk calculator, which enables the calculation of an individual's risk of developing pneumonia, can serve as a supportive tool for clinical decision-making.
This is an observational study. Patient evaluation and treatment will be conducted in strict accordance with approved standards of medical care for the respective conditions. No experimental or unregistered (not approved for use) medical or diagnostic methods will be utilized in this study.
The study involves the systematic collection of data from the medical records of patients who undergo cardiac and/or vascular surgery during their current hospitalization. These data will be analyzed using artificial intelligence (AI) technologies, including machine learning methods such as gradient boosting, random forest, neural networks, Bayesian networks, and others.
This is a multicenter study involving three participating centers: Tomsk National Research Medical Center of the Russian Academy of Sciences, Tomsk State University, and the Federal State Budgetary Institution Research Institute for Complex Issues of Cardiovascular Diseases.
In phase 1, data will be collected from at least 400 patients undergoing cardiac surgery at a single center (Tomsk National Research Medical Center of the Russian Academy of Sciences). An anonymized database will be created, including the following parameters:
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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;
- •Cardiac and/or vascular surgical intervention during the current hospitalization;
- •Signed informed consent from the patient for the use of their anonymized data for scientific purposes.
排除标准
- •Use of systemic antibacterial drugs within 30 days prior to the surgical intervention;
- •Prescription of systemic antibacterial drugs during the hospitalization period for any indication other than hospital-acquired pneumonia;
- •HIV infection.
研究组 & 干预措施
Patients after cardiovascular surgery
Patients of 18 years and older, after cardiac and/or vascular surgical intervention during the current hospitalization, who signed informed consent for the use of their anonymized data for scientific purposes
干预措施: Not applicable- observational study (Other)
结局指标
主要结局
Hospital acquired pneumonia
时间窗: Within 30 days post-surgery
Occurrence of hospital-acquired pneumonia
Composite cardiovascular and pulmonary endpoint
时间窗: 12 months post-surgery
Occurrence of the composite cardiovascular and pulmonary endpoint
次要结局
- Non-pneumonia postoperative complications(Within 30 days post-surgery)
- Composite Pulmonary Outcome(12 months post-surgery)
- Composite Cardiovascular Outcome(12 months post-surgery)