NCT03536130

Comparison Between Electronic and Traditional Chest Drainage Systems

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 382 (estimated)
• Sponsor: University Hospital Padova · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Lung Cancer

Interventions

Type	Name	Description
DEVICE	Electronic chest drainage system	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

Timeline

• Start date: 2017-04-04
• Primary completion: 2020-03-31
• Completion: 2020-03-31
• First posted: 2018-05-24
• Last updated: 2019-10-02

Locations

4 sites across 1 country: Italy