Comparison Between Electronic and Traditional Chest Drainage Systems

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

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.

Inclusion Criteria:

• Able and willing to read, understand and provide written informed consent
• Patients undergoing thoracoscopic lobectomy
• Age 18 - 80 years
• Gender: both
• Estimated life expectancy of at least 6 months.
• Tumour considered potentially resectable by R0 surgery
• Adequate respiratory function for surgery.
• Must have signed and dated an informed consent form (ICF), before performance of any study-specific procedures or tests. Subjects must be fully informed about their illness and the investigational nature of the study protocol.

Exclusion Criteria:

• Patients requiring ICU care with mechanical ventilation
• Patients needing reintervention during postoperative care
• Patients requiring a thoracotomy
• Tumour considered potentially resectable by incomplete surgical resection with microscopic residual disease (R1) or gross residual disease (R2).
• Evidence of extra-thoracic disease.
• Major thoracic surgical procedure before enrolment.
• Any other significant co-morbid condition that, in opinion of the investigator, would impair study participation or cooperation.