Multicenter randomized study on comparison between electronic and traditional chest drainage systems

Abstract Background: In patients submitted to major pulmonary resection, post-operative length of stay is mainly influenced by duration of air leaks and chest tube removal. The measurement of air leaks largely relies on traditional chest drainage systems which are prone to subjective interpretation. Difficulty in differentiating between active air leaks and bubbles due to a pleural space effect may also lead to tentative drain clamping and prolonged time for chest drain removal. New digital systems allow continuous monitoring of air leaks, identifying subtle leakage that may be not visible during daily patient evaluation. Moreover, an objective assessment of air leaks may lead to a reduced interobserver variability and to an optimized timing of chest tube removal. Methods: This study is a prospective randomized, interventional, multicenter trial designed to compare the electronic chest drainage system (Drentech™ Palm Evo) with the traditional one (Drentech™ Compact) in a cohort of patients undergoing pulmonary lobectomy through a standard 3-ports VATS approach both for benign or malignant disease. It will enroll 382 patients in 3 Italian centers. Duration of chest drainage and length of hospital stay will be evaluated in the two groups. Moreover, it will be evaluated if the use of a digital chest system compared with a traditional system reduces theinterobserver variability. Finally, it will be evaluated if the digital drain system may help in distinguishing an active air leak from a pleural space effect, by the digital assessment of intrapleural differential pressure, and in identifying potential predictors of prolonged air leaks. Discussion : To date, few studies have been performed to evaluate clinical impact of digital drainage systems. The proposed prospective randomized trial will provide new knowledge to this research area by investigating and comparing the difference between digital and traditional chest drain systems. In particular, the objectives of this project are to evaluate the feasibility and usefulness of digital chest drainages and to provide new tools to identify patients at higher risk of developing prolonged air leaks.