An interventional study of Electronic chest drainage system in Lung Cancer, sponsored by University Hospital Padova. Status unknown at 4 sites in Italy. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-10-02.
Sponsored by University Hospital Padova · Not applicable, Interventional, and Other
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.
University Hospital Padova is the lead sponsor of 41 studies on the registry; 10 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Device: Electronic chest drainage system
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
Duration of chest drainage
Time frame: from date of surgery to date of chest tube removal, assessed up to 8 days
Post-operative hospital length of stay
Time frame: from date of surgery to date of hospital discharge, assessed up to 8 days
Evaluation of the degree of concordance between the subjective observer evaluation of active air leaks compared with the objective data registered by the digital system in the patients with electronic chest drainage system
Time frame: from date of surgery to date of chest tube removal, assessed up to 8 days
Evaluation of intrapleural differential pressure in case of active air leak and in case of pleural space effect
Time frame: from date of surgery to date of chest tube removal, assessed up to 8 days
Identification of potential predictors of prolonged air leaks through the analysis of the data registered by the digital system
Time frame: from date of surgery to date of chest tube removal, assessed up to 8 days
This study is status unknown, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
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University Hospital Padova