Validation of a System Using Aerosol Glycerine to Detect and Localize Intraoperatively Pulmonary Air Leaks

What this Trial Is About

Air leaks are common complications after thoracic surgery, especially after lung removal procedures, causing increased hospital stays and costs. This trial evaluates a new system that creates and sends glycerine aerosol smoke into the lungs during surgery. The smoke is visible with standard laparoscopes and helps detect and locate air leaks, which could reduce complications and improve recovery for patients undergoing lung surgery. The system is tested primarily on lungs removed from transplant patients, where a controlled leak is created. Surgeons use a laparoscope to locate leaks using the glycerine aerosol smoke, comparing this method to the current standard submersion test where lungs are submerged in saline to identify leaks by air bubbles. The goal is to establish a reliable, standardized protocol for using this system efficiently during surgery. Participants will include patients undergoing lung transplant surgery or organ donors not eligible to donate lungs. Researchers will measure how well and how quickly the system localizes leaks, the smallest leak detected, and the airtightness of staple lines used in lung surgery. The study will last up to 48 months, with no masking or placebo, focusing on improving detection methods for pulmonary air leaks.

Validation of a System Using Aerosol Glycerine to Detect and Localize Intraoperatively Pulmonary Air Leaks