Table 1 Clinical safety evaluation in perioperative period: any of the listed conditions is considered a complication of the perioperative period
1 | Postoperative arrhythmia | Postoperative atrial fibrillation, atrial flutter, supraventricular tachycardia, ventricular tachycardia, ventricular fibrillation, ventricular flutter, cardiac arrest, atrioventricular block of 2nd degree or above, frequent atrial premature beat and ventricular premature beat significantly affecting the stability of hemodynamics (indicated in electrocardiogram [ECG]) | ||
2 | Pneumonia | Body temperature above 38.5 °C (indicated in chest film) | ||
3 | Acute lung injury | (1) Acute onset, with pathogenic factors | ||
(2) Oxygenation index (arterial partial pressure of oxygen/fraction of inspired oxygen, PaO2/Fi02) < 300 mmHg (1 mmHg = 0.133 kPa) not referring to positive end-expiratory pressure (PEEP) level | ||||
(3) Frontal X-ray chest film revealed patchy shadows in both lungs | ||||
(4) Pulmonary artery incarceration pressure < 18 mmHg or no clinical evidence of increased pressure in left atrium | ||||
(5) Acute paroxysmal respiratory failure | ||||
4 | Pulmonary atelectasis | Indicated in chest film | ||
5 | Intraoperative and postoperative myocardial infarction | Manifestation of myocardial infarction symptoms or change of ECG ST segment, continuous increase of myocardial enzyme, especially cardiac troponin I (cTnI), accompanied with dynamic change of ST segment | ||
6 | Postoperative cardiac insufficiency | The postoperative cardiac output (CO) is lower than lower limit of normal value or there are symptoms and vital signs of heart failure | (1) Left cardiac insufficiency | Symptoms: dyspnea; coughing, expectoration, and hemoptysis; cyanosis, fatigue, and weakness |
Vital signs: expansion of border of cardiac dullness, left lower shifting of cardiac impulse with elevating sensation. Accelerated heart rate, diastolic gallop heard in apex, alternative pulse in severe case. Moist and dry rales are heard in the bottom of both lungs. Wheezing rale and dry rales may be accompanied with secondary bronchial spasm | ||||
(2) Right cardiac insufficiency | Symptoms: reduced urine volume, increased nocturnal enuresis, swelling pain in liver region or even occurrence of jaundice; inappetence, dyspepsia, nausea, vomiting and diarrhea | |||
Vital signs: expansion of border of cardiac dullness, apex beating showing elevating sensation, diffuse beating range, accelerated heart rate | ||||
Distention of jugular vein, liver swelling with tenderness, hepatojugular reflux sign positive; pitting edema, right heart failure | ||||
Typical vital signs of failure, mostly in the body drooping part | ||||
(3) Whole cardiac insufficiency | Coexistence of clinical manifestations of left and right cardiac insufficiency, but principally one of them | |||
7 | Postoperative respiratory insufficiency | Patients showing intracardiac anatomical shunt and cardiac volume decrease when they breath in indoor air at static conditions will be excluded; arterial partial pressure of oxygen (PaO2) is lower than 8 kPa (60 mmHg) or accompanied with partial pressure of carbon dioxide (PaCO2) higher than 6.65 kPa (50 mmHg) | ||
8 | Postoperative hemorrhage of digestive tract | Ulcer bleeding or bloody gastric content caused by mucosal ischemia of gastrointestinal tract, hematemesis, tarry stool or hemafecia | ||
9 | Postoperative hepatic insufficiency | Severe hepatocellular damage, causing significant metabolism, secretion, synthesis, biotransformation, and immune function disorder, clinical syndrome of edema in the organism, jaundice, hemorrhage, infection, renal function disorder, and hepatic encephalopathy, etc. | ||
Postoperative renal insufficiency | Rapid decrease of renal excretory function in short term, and daily mean increase of serum creatinine ≥ 44.2 μmol/L and exacerbation of existing renal insufficiency | |||
10 | Postoperative infection other than lung infection | Including hematogenous infection, infections of digestive tract, urinary system, wound, skin, and indwelling catheter | ||
11 | Postoperative cerebral ischemia and hypoxic disease | Including cerebral infarction, cerebral thrombosis, cerebral hemorrhage, transient cerebral ischemic attack, and diffuse cerebral ischemia and hypoxic disease | ||
12 | Prolongation of postoperative hospital stay | Postoperative hospital stay exceeds 14 days | ||
13 | Acute kidney injury | (1) Increase of plasma creatinine within 48 h ≥ 0.3 mg/dL (≥ 26.5 μmol/L) | ||
(2) Plasma creatinine within 7 days ≥1.5 times the basic value | ||||
(3) Urine volume within 6 h lower than 0.5 ml/kg/h | ||||
14 | Death in perioperative period: definition | (1) Death within 30 days after surgery | ||
(2) Death in hospital stay after surgery | ||||
(3) Death caused by surgical reasons after discharge | ||||