Flow-Controlled Ventilation to Improve Postoperative Pulmonary Outcome After Thoracic Surgery

In an international multicenter randomized clinical pilot trial, intraoperative flow-controlled ventilation (FCV) will be compared with volume-controlled ventilation (VCV) in patients scheduled for (open, video- or robot-assisted) thoracic surgery with one-lung ventilation (OLV). This pilot trial is designed to test the feasibility and safety of FCV during all phases of intraoperative ventilation, and in particular during OLV, and to inform the design of a future trial testing the efficacy of FCV with regard to postoperative outcomes, including postoperative pulmonary complications (PPC). The ventilation modes are conducted with CE-marked medical devices (anesthesia ventilators or medical ventilators), however these medical devices themselves are not under investigation. All CE-marked standard medical devices from varied manufacturers in use at the participating study centers will be used in full accordance with their instructions for use. FCV has shown safety and feasibility in various surgical settings, including thoracic surgery with OLV, however its feasibility in a multicenter trial has not been investigated yet.

Inclusion Criteria: * aged ≥ 18 years; and * scheduled for elective open, video- or robot-assisted thoracic surgery with one-lung ventilation using a double-lumen tube (DLT); and * able to give written informed consent. Exclusion Criteria: * body weight \< 40 kg; * ASA score IV - VI; * lung separation with other method than DLT (e.g. difficult airway, tracheostomy); * previous lung surgery; * COPD GOLD grades III and IV, lung fibrosis, documented bullae, severe emphysema, pneumothorax; * uncontrolled asthma; * Heart failure NYHA Grade 3 and 4, Coronary Heart Disease CCS Grade 3 and 4; * documented pulmonary arterial hypertension \>25 mmHg mPAP at rest or \>40mmHg syst. (estimated by ultrasound) or \>20 mmHg mPAP measured by right heart catheterization, or pulmonary vascular resistance \> 2.0 Wood units; * documented or suspected neuromuscular disease (thymoma, myasthenia, myopathies, muscular dystrophies, others); * planned mechanical ventilation after surgery; * bilateral procedures; * surgery in prone position; * persistent hemodynamic instability, intractable shock; * intracranial injury or tumor; * esophagectomy, pleural surgery only, sympathectomy surgery only, chest wall surgery only, mediastinal surgery only, lung transplantation; * presence before induction of anesthesia of one of the adverse events, listed as postoperative pulmonary complications (aspiration, moderate respiratory failure, infiltrates, pulmonary infection, atelectasis, cardiopulmonary oedema, pleural effusion, pneumothorax, pulmonary embolism, purulent pleuritis, lung hemorrhage); * documented preoperative hypercapnia \> 45mmHg (6kPa) * previous enrolment in the current study; * being the study investigator of this study, his/her family members, employees and other dependent persons; * if female and of childbearing potential, known pregnancy or a positive urine pregnancy test (confirmed by a positive serum pregnancy test), or lactating; or * no written informed consent.