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| Name | Class |
|---|---|
| The Leeds Teaching Hospitals NHS Trust | OTHER |
| The University of Hong Kong | OTHER |
| Yale University | OTHER |
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Electronic system | Experimental | patients managed with an electronic chest drainage system |
|
| traditional system | No Intervention | patients managed with a traditional analogue chest drainage system |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| electronic chest drainage system | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of chest tubes | date of chest tube removal |
| Measure | Description | Time Frame |
|---|---|---|
| total distance of ambulation in the first 48 postoperative hours | 48 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| overall patient satisfaction with chest drainage system. | 48 hours after surgery |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cecilia Pompili, MD | Ospedali Riuniti Ancona, Italy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedali Riuniti Ancona | Ancona | 60122 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24906602 | Derived | Pompili C, Detterbeck F, Papagiannopoulos K, Sihoe A, Vachlas K, Maxfield MW, Lim HC, Brunelli A. Multicenter international randomized comparison of objective and subjective outcomes between electronic and traditional chest drainage systems. Ann Thorac Surg. 2014 Aug;98(2):490-6; discussion 496-7. doi: 10.1016/j.athoracsur.2014.03.043. Epub 2014 Jun 4. |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D017060 | Patient Satisfaction |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |