Pneumonia After Cardiovascular Surgery With Artificial Intelligence

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorTomsk National Research Medical Center of the Russian Academy of Sciences

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

Patients of 18 years and older after cardiac and/or vascular surgical intervention during the current hospitalization

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

  • Not applicable- observational study

    Other intervention

    Not applicable- observational study

Treatment groups

700 Participants
are divided into 1 treatment group
Group A: Patients after cardiovascular surgery1 intervention

Trial outcomes

Primary outcomes

1

Hospital acquired pneumonia

Occurrence of hospital-acquired pneumonia

Time frame
Within 30 days post-surgery
2

Composite cardiovascular and pulmonary endpoint

Occurrence of the composite cardiovascular and pulmonary endpoint

Time frame
12 months post-surgery

Secondary outcomes

1

Non-pneumonia postoperative complications

Incidence of non-pneumonia postoperative complications (surgical site infections, cardiac events, etc.)

Time frame
Within 30 days post-surgery
2

Composite Pulmonary Outcome

Incidence of the Composite Pulmonary Outcome: Respiratory death; Hospitalization due to respiratory diseases; New-onset oxygen dependence; New-onset asthma, chronic obstructive pulmonary disease (COPD), or interstitial lung disease (ILD); Initiation or intensification of bronchodilator or corticosteroid therapy

Time frame
12 months post-surgery
3

Composite Cardiovascular Outcome

Incidence of the Composite Cardiovascular Outcome: Cardiovascular death; Acute myocardial infarction; Unstable angina; Myocardial revascularization; Acute ischemic stroke (acute cerebrovascular accident); Transient ischemic attack (TIA); Acute heart failure; Hospitalization for decompensated heart failure; New-onset atrial fibrillation or ventricular tachycardia; Initiation or intensification of antiarrhythmic therapy

Time frame
12 months post-surgery

Other outcomes

Sponsors and contacts

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Tomsk National Research Medical Center of the Russian Academy of Sciences

Lead sponsor

National Research Tomsk State University

Collaborator

Research Institute for Complex Problems of Cardiovascular Diseases, Russia

Collaborator