Multicenter randomized study on the comparison between electronic and traditional chest drainage systems. 2019

Giuseppe Marulli, and Giovanni M Comacchio, and Mario Nosotti, and Lorenzo Rosso, and Paolo Mendogni, and Giuseppe Natale, and Luigi Andriolo, and Giovanna Imbriglio, and Valentina Larocca, and Debora Brascia, and Federico Rea
Thoracic Surgery Unit, Department of Organ Transplantation and Emergency, University Hospital of Bari, Piazza Giulio Cesare, 11, 70124, Bari, Italy. giuseppe.marulli@uniba.it.

BACKGROUND In patients submitted to major pulmonary resection, the postoperative length of stay is mainly influenced by the 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 for chest tube removal. METHODS This study is a prospective randomized, interventional, multicenter trial designed to compare an electronic chest drainage system (Drentechâ„¢ Palm Evo) with a traditional system (Drentechâ„¢ Compact) in a cohort of patients undergoing pulmonary lobectomy through a standard three-port video-assisted thoracic surgery approach for both benign and malignant disease. The study will enroll 382 patients in three Italian centers. The duration of chest drainage and the length of hospital stay will be evaluated in the two groups. Moreover, the study will evaluate whether the use of a digital chest system compared with a traditional system reduces the interobserver variability. Finally, it will evaluate whether 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. CONCLUSIONS To date, few studies have been performed to evaluate the 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. BACKGROUND ClinicalTrials.gov, NCT03536130. Retrospectively registered on 24 May 2018.

UI MeSH Term Description Entries
D007558 Italy A country in southern Europe, a peninsula extending into the central Mediterranean Sea, northeast of Tunisia. The capital is Rome. Sardinia
D007902 Length of Stay The period of confinement of a patient to a hospital or other health facility. Hospital Stay,Hospital Stays,Stay Length,Stay Lengths,Stay, Hospital,Stays, Hospital
D008297 Male Males
D008875 Middle Aged An adult aged 45 - 64 years. Middle Age
D011013 Pneumonectomy The excision of lung tissue including partial or total lung lobectomy. Bronchoscopic Lung Volume Reduction,Endoscopic Lung Volume Reduction,Lung Volume Reduction,Lung Volume Reduction Surgery,Partial Pneumonectomy,Partial Pneumonectomies,Pneumonectomies,Pneumonectomy, Partial,Reduction, Lung Volume,Volume Reduction, Lung
D011030 Pneumothorax An accumulation of air or gas in the PLEURAL CAVITY, which may occur spontaneously or as a result of trauma or a pathological process. The gas may also be introduced deliberately during PNEUMOTHORAX, ARTIFICIAL. Pneumothorax, Primary Spontaneous,Pressure Pneumothorax,Primary Spontaneous Pneumothorax,Spontaneous Pneumothorax,Tension Pneumothorax,Pneumothorax, Pressure,Pneumothorax, Spontaneous,Pneumothorax, Tension,Spontaneous Pneumothorax, Primary
D004322 Drainage The removal of fluids or discharges from the body, such as from a wound, sore, or cavity.
D004582 Electronics, Medical The research and development of ELECTRICAL EQUIPMENT AND SUPPLIES for such medical applications as diagnosis, therapy, research, anesthesia control, cardiac control, and surgery. (From McGraw-Hill Dictionary of Scientific and Technical Terms, 6th ed) Medical Electronics
D005260 Female Females
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man

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