Not Yet RecruitingNot Applicable

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

Switzerland140 participantsStarted 2026-09-01

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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, pleur…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Feasibility (Proportion of Full Adherence to the Ventilation Protocols)

Timeframe: From enrollment to the end of intraoperative surgical procedures at the day of surgery.

Trial details

NCT IDNCT07623395

SponsorCantonal Hospital of St. Gallen

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-09-01

Contact for this trial

Timur Yurttas, MD

0041714949158 info@proflow-series.org

View on ClinicalTrials.gov More Mechanical Ventilation trials