postoperative pulmonary complications
Conditions
Brief summary
postoperative pulmonary complications (PPC) at D7 post thoracic surgery
Detailed description
Post-operative pulmonary complications at D7 and interaction between group with/without bronchodilator and ARISCAT score, Post-operative pulmonary complications at D7 and interaction between the group with/without bronchodilator and the presence or absence of COPD., Post-operative pulmonary complications at D7 and interaction between the bronchodilator/no bronchodilator group and long-term inhaled anticholinergic therapy, Post-operative pulmonary complications at D28 (assessed as for primary endpoint), Pulmonary function by spirometry on D7 (or day of discharge if earlier) and D28 post-op (measured with the Spirolab® Spirometer validated for bed-side measurements: [including: forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC), Tiffeneau ratio = FEV1/FVCx 100, peak expiratory flow (PEF)] etc.)., Cardiovascular complications (cardiac arrhythmia, acute myocardial infarction according to the 4th universal definition, ischemic or hemorrhagic stroke) at D28 post-op., Postoperative survival status, Quality of life assessed at D7 (or discharge), D28 and 6 months post-operatively using the standardized questionnaire [EuroQol-5D (EQ-5D)] via remote telephone cal, - Potential treatment-related adverse events (investigated daily in hospital): o Flushing o Dry mouth, dysgeusia o Headaches, tremors o Palpitations, atrial fibrillation, extrasystoles, tachycardia (> 100/min over 24h), prolonged QTc (> 450 ms in men and 470 ms in women) o Hypokalemia (< 3.5mmol/l) o Hyperglycemia (> 10 mmol/L)
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| postoperative pulmonary complications (PPC) at D7 post thoracic surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| Post-operative pulmonary complications at D7 and interaction between group with/without bronchodilator and ARISCAT score, Post-operative pulmonary complications at D7 and interaction between the group with/without bronchodilator and the presence or absence of COPD., Post-operative pulmonary complications at D7 and interaction between the bronchodilator/no bronchodilator group and long-term inhaled anticholinergic therapy, Post-operative pulmonary complications at D28 (assessed as for primary endpoint), Pulmonary function by spirometry on D7 (or day of discharge if earlier) and D28 post-op (measured with the Spirolab® Spirometer validated for bed-side measurements: [including: forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC), Tiffeneau ratio = FEV1/FVCx 100, peak expiratory flow (PEF)] etc.)., Cardiovascular complications (cardiac arrhythmia, acute myocardial infarction according to the 4th universal definition, ischemic or hemorrhagic stroke) at D28 post-op., Po | — |
Countries
France