Objective and Subjective Outcomes of an Electronic Chest Drainage System
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 Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||Objective and Subjective Outcomes of an Electronic Chest Drainage System Versus Traditional Devices: a Randomized Comparison|
- Duration of chest tubes [ Time Frame: date of chest tube removal ] [ Designated as safety issue: No ]
- total distance of ambulation in the first 48 postoperative hours [ Time Frame: 48 hours after surgery ] [ Designated as safety issue: No ]
- overall patient satisfaction with chest drainage system. [ Time Frame: 48 hours after surgery ] [ Designated as safety issue: No ]
|Study Start Date:||January 2013|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Experimental: Electronic system
patients managed with an electronic chest drainage system
Device: electronic 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
No Intervention: traditional system
patients managed with a traditional analogue chest drainage system
Please refer to this study by its ClinicalTrials.gov identifier: NCT01747889
|Contact: Cecilia Pompili, MDfirstname.lastname@example.org|
|Ospedali Riuniti Ancona||Recruiting|
|Ancona, Italy, 60122|
|Contact: Cecilia Pompili, MD +390715964439 email@example.com|
|Principal Investigator: Cecilia Pompili, MD|
|Principal Investigator:||Cecilia Pompili, MD||Ospedali Riuniti Ancona, Italy|