pulmonary surgery, cancer, postoperative complications longchirurgie, kanker, postoperatieve complicaties
Conditions
Interventions
none
Sponsors
Amphia Hospital
Eligibility
Inclusion criteria
Inclusion criteria: Elective pulmonary surgery (pneumonectomy, (bi)(sleeve)lobectomy, segmentectomy) for cancer, American Society of Anesthesiologists (ASA) physical status classification ≥2 with a planned postoperative admission to the Intensive Care.
Exclusion criteria
Exclusion criteria: (suspected) Infection at the time of surgery and reoperation within 24 hours of surgery will be excluded from the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint is the development of an infectious complication which is defined as one of the following outcomes within 30 days of surgery: -pneumonia (purulent sputum, positive sputum or blood culture and clinical symptoms such as cough, fever or consolidation on chest radiograph) -pulmonary empyema (pleural effusion and the presence of pus on pleural aspiration, microorganism on pleural fluid culture or positive pleural fluid Gram stain) -sepsis (qSOFA score ≥2 in response to an infection) -wound infection (purulent drainage from superficial incision or deliberate opening of superficial incision by surgeon and pain, tenderness, swelling or redness) -urinary tract infection (urinary tract symptoms or fever and urine culture with no more than 2 species of organisms identified with at least one of which is a bacterium of ≥105 CFU/ml) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoint is the development of a non-infectious complication which is defined as one of the following outcomes within 30 days of surgery: - acute kidney injury (increase in serum creatinine by ≥ 26 µmol/l, a percentage increase in serum creatinine of more than or equal to 50% or oliguria of less than 0.5 ml/kg per hour for more than six hours within 48 hours) - respiratory insufficiency (hypoxia or hypercapnia leading to ICU (re)admission) - reoperation - supraventricular arrhythmia (new-onset atrial fibrillation or atrial flutter) - congestive heart failure (pleural effusion or pulmonary edema requiring diuretic therapy) - acute respiratory distress syndrome (defined as diffuse inflammatory lung injury (onset over 1 week or less), bilateral opacities consistent with pulmonary edema must be present and may be detected on CT or chest radiograph, PF ratio <300mmHg with a minimum of 5 cmH20 PEEP (or CPAP) must not be fully explained by cardiac failure or fluid overload - pulmonary embolus (filling defect ≥ 75% in a pulmonary artery with corresponding normal ventilation - stroke (clinical diagnosis of acute transient ischemic attack (TIA) or cerebrovascular accident (CVA)) - myocardial infarction (elevated hs-cTn in combination with clinical symptoms or electrocardiography changes) - mortality | — |
Contacts
Public ContactT. Rettig
Amphia Hospital
Outcome results
None listed