Postoperative Pulmonary Complications (PPCs), Thoracic Surgery
Conditions
Keywords
Thoracic surgery, postoperative pulmonary complications, Inhaled therapy, bronchodilators, B2 mimetics
Brief summary
The objective of the study is to evaluate, in a clinical trial, the efficacy of peri operative administration of long-acting inhaled ß-2 mimetics on the occurrence of postoperative pulmonary complications
Interventions
Administration in the interventional arm of long-acting inhaled ß-2 mimetics: FORMOTEROL FUMARATE 12 µg pwd inhalation capsule (FORMOTEROL VIATRIS®), taken twice a day intraoperatively from Day-2 to Day 7.
usual treatment
Sponsors
Study design
Eligibility
Inclusion criteria
* Adult (\>18 years) * Lung cancer eligible for surgical management by lung resection (non-small cell lung carcinoma = NSCLC) by any route * Naïve to long-term inhaled bronchodilator therapy * High risk of post-operative pulmonary complications (Pre-operative FEV1 \< 80%)
Exclusion criteria
* Patient refusal * Pregnancy * Emergency surgery * Patient with a physiological status of WHO IV or ASA ≥ IV * Asthma * Patients treated with long-acting bronchodilators * Severe heart failure (NYHA IV), unstable ischaemic heart disease (angina or recent infarction \< 3 months), obstructive hypertrophic cardiomyopathy, subvalvular aortic stenosis, severe uncontrolled hypertension Recent stroke \< 3 months * High-grade unresponsive conductive disorders or unstable arrhythmia * Thyrotoxicosis, pheochromocytoma * Unbalanced diabetes * Hypersensitivity to ß-2 mimetics or lactose * Current participation in a trial of another drug therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of postoperative pulmonary complication | day 7 | Number of postoperative pulmonary complications (PPC) at day 7 after a thoracic surgery for lung resection |
Countries
France