Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Patients in the intervention arm are connected to Drentech Palm Evo with single standard chest tube (28 Ch) immediately after closure of the chest. Patients with digital devices are managed by setting the pump to -20 cmH2O until the morning of postoperative day (POD) 1 and then setting the pump on physiologic mode (0 cmH2O) thereafter.

Patients in the no intervention (traditional) arm are connected to traditional drain system with single standard chest tube (28 Ch) immediately after closure of the chest. Patients with traditional devices (requiring connection to wall suction) are managed by applying suction (-20 cmH2O) until the morning of POD 1 and are subsequently disconnected from suction thereafter.

Patients in the intervention arm are connected to Drentech Palm Evo with single standard chest tube (28 Ch) immediately after closure of the chest. Patients with digital devices are managed by setting the pump to -20 cmH2O until the morning of postoperative day (POD) 1 and then setting the pump on physiologic mode (0 cmH2O) thereafter. Management of chest tube drainage and decision for chest tube removal will be dictated by clinical signs, symptoms and surgeon preference following standard clinical practice of general thoracic patients

Electronic chest drainage system

Giuseppe Marulli, MD, PhD

Giovanni Comacchio, MD

Gaetano Di Rienzo

Camillo Lopez

Mario Nosotti

Paolo Mendogni

Carlo Curcio

Rosario Salvi

Federico Rea, MD

This study is designed to compare the electronic chest drainage system (Drentech Palm Evo) with the traditional system, both already in use in the clinical practice, in a cohort of patients who received thoracoscopic lobectomy. This study is not evaluating safety or efficacy of these systems.

This study's primary aim is to determine if the use of a digital chest system compared with a traditional system reduce the duration of chest drainage and length of hospital stay. Moreover, the investigators aim to quantify the variability of results regarding the subjective observer evaluation of active air leaks (through the traditional system) compared with the objective data registered by the digital system.

Finally the investigators want to evaluate whether it is possible through the digital device 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.

Allocation: randomization 1 to 1 Endpoint classification: efficacy study Masking: Open label Intervention model: parallel assignment Primary purpose: supportive care

Comparison Between Electronic and Traditional Chest Drainage Systems

Multicenter Randomized Study on Comparison Between Electronic and Traditional Chest Drainage Systems

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Vito Fazzi Hospital

Monaldi Hospital

University Hospital Padova

MD, PhD

patients managed with an electronic chest drainage system

patients managed with a traditional analogue chest drainage system

Patients in the intervention arm are connected to Thopaz, electronic drainage system immediately after closure of the chest, patients in the control group are connected to a traditional system. Chest tubes in both groups are then connected to suction of -20 cmH2O and maintained at that level until post-operative day #1.

On the morning of post-operative day #1, presence of air leak will be recorded on suction. Then, suction will be decreased to -8 cmH2O (so-called water seal). At that time, management of chest tube drainage and decision for chest tube removal will be dictated by clinical signs, symptoms, and surgeon preference following the standard clinical algorithm for post-operative care of general thoracic patients

electronic chest drainage system

Cecilia Pompili, MD

This study is designed to compare the Thopaz chest tube drainage system to the traditional collection chamber system. The Thopaz system is already in clinical use in the United States and throughout the world. As such, this study is not evaluating safety or efficacy of this system both of which have already been demonstrated. This study's primary aim is to determine whether the use of a digital chest drainage system compared with a traditional system affects duration of chest drainage and length of hospital stay.

Furthermore, we aim to determine whether the use of a digital chest drainage system compared with a traditional system increases the total distance of ambulation in the first 48 hours after thoracic surgery and affects overall patient satisfaction in the peri-operative period.

Finally, we want to determine whether the aforementioned outcomes relative to the chest tube drainage systems differ in different parts of the world.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Comparison Between Electronic and Traditional Chest Drainage Systems	NCT03536130	Lung Cancer	Electronic ches...	18 Years - 80 Years	University Hospital Padova
Objective and Subjective Outcomes of an Electronic Chest Drainage System	NCT01747889	Lung Cancer	electronic ches...	18 Years - 90 Years	Ospedali Riuniti Ancona
Objective and Subjective Outcomes of an Electronic Chest Drainage System	NCT01747889	Lung Cancer	electronic ches...	18 Years - 90 Years	Ospedali Riuniti Ancona

Spots Global Cancer Trial Database for electronic chest drainage system