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 to differentiate 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 system (Drentech™ Compact) in a cohort of patients undergoing pulmonary lobectomy through a standard 3-ports VATS approach 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 the interobserver variability. Finally, it will be evaluated the possible advantages of the digital drain system to distinguish an active air leak from a pleural space effect, by the evaluation of intrapleural differential pressure, and to identify 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 utilizing the digital chest drain and to provide new tools to identify patients at higher risk of developing prolonged air leaks. Trial registration number NCT03536130, Registered 24 May 2018 - Retrospectively registered, https://clinicaltrials.gov/ct2/results?cond=&term=NCT03536130&cntry=&state=&city=&dist=