Cardiovascular diseases
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1) Scheduled elective non-cardiac surgery with intermediate to high risk for cardiac complications 2) General anesthesia with endotracheal intubation 3) Signed informed consent of the participant
Exclusion criteria
Exclusion criteria: 1) Instable cardiac condition (Acute coronary syndrome, Acute heart failure, Tachyarrhythmia or Bradyarrhythmia, symptomatic Aortic stenosis) 2) Emergency surgery 3) Relative contraindication to perform a bronchoalveolar lavage (BAL) (Volume of air exhaled under forced conditions in the first second < 1000 mL, hypercapnia, hypoxemia, hemorrhagic diathesis) 4) Pregnancy 5) Breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Concentration of bacterial DNA in copies/per mL of bronchoalveolar lavage measured by quantitative polymerase chain reaction after induction of general anesthesia. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Number of unique bacterial species within a sample (alpha diversity, Shannon index). • Comparison of the composition of the microbiome between the different groups (beta diversity, Jaccard index). • Bacterial load, composition and diversity of the microbiome in the nasopharynx and comparison with the pulmonary microbiome. • ILC cell count and composition in the BAL and blood. • Inflammation markers (cellular and humoral) in the BAL and in the blood. • Cardiac markers (natriuretic peptides, cardiac troponin). • Frequency of perioperative complications based on the European Perioperative Clinical Outcome (EPCO) definition, including cardiovascular complications (MACE) (=major adverse cardiac and cerebrovascular event) • Severity of perioperative complications (classification based on the Clavien and Dindo classification). • Mortality (30, 60 and 180 days postoperative). • Need for and duration of treatment in an intensive care unit (days). • Duration of hospital treatment (days). • Necessity and duration of artificial respiration (hours). • Incidence of postoperative delirium. • Incidence of postoperative infections/sepsis (including urinary tract infection, pneumonia and acute respiratory distress syndrome). • Incidence of perioperative acute kidney injury. • Cardiac function using transthoracic echocardiography (TTE). • Cardiac function using magnetic cardiography (MCG). Change in health status (health-related quality of life) using patient-reported outcomes (PROs) • Survey using the standardized 5-dimensional-5-level EuroQoL (EQ-5D-L) questionnaire. | — |
Countries
Germany
Contacts
Klinik für Anästhesiologie mit Schwerpunkt operative Intensivmedizin | CBF, Charité - Universitätsmedizin Berlin