Prospective, Non Randomized Investigator Initiated Multi-centre Trial on the Effects of Local Treatment Protocols on the Duration of Chest Tube Therapy Following Thoracic Surgery in Germany
| Registry | NCT01467622 |
|---|---|
| Status | Completed |
| Study type | Observational |
| Enrollment | 80 (Actual) |
| Sponsor | Schillerhoehe Hospital (Other); collaborators: Medela AG |
| Conditions | Pulmonary Air Leak |
| Interventions | Chest tube removal (Procedure) |
| Dates | start 2009-04-01, primary completion 2009-08-01, completion 2011-10-01, first posted 2011-11-09, last updated 2013-05-07 |
| Locations | 4 sites in Germany |
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The effect of local chest-tube management protocols on the duration of chest-tube therapy following thoracic surgery was analyzed in four German specialized Thoracic Surgery Units. The primary study objective was the duration of chest tube therapy in postoperative patients.
The management of chest tubes is probably one of the most critical aspects in patient care in thoracic surgery and defines the required length of postoperative hospital stay in the majority of patients. So far, no generally accepted recommendations exist for postoperative chest tube management to streamline the postoperative stay. Instead, decision making in most thoracic surgery units is based on team preferences and individual training rather than scientific data. Therefore, digital pleural drainage systems represent a useful tool to standardize existing intradepartmental protocols for chest tube management. However, for the development of generally accepted protocol-recommendations, the diverging interdepartmental treatment protocols have to be analyzed and compared for superiority. In this IIT, the effect of different chest tube management protocols on chest tube duration is analyzed in four German Thoracic Surgery units.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Study population | Procedure: Chest tube removal | Patients undergoing elective pulmonary wedge resection, anatomic segmentectomy, or lobectomy. |
Sex: All, ages: 18 Years to 85 Years
Inclusion Criteria: * age 18-85 * following pulmonary wedge resection, anatomic segmentectomy, or lobectomy Exclusion Criteria: * surgery for spontaneous pneumothorax (primary and secondary) * surgery for pleural empyema * present medication with corticoids, immunosuppressive drugs or platelet aggregation inhibitors other than Aspirin * history of chemotherapy, radiotherapy of the chest, or previous ipsilateral thoracic surgery
| Facility | City | Country | Status |
|---|---|---|---|
| Evangelische Lungenklinik Berlin | Berlin | Germany | |
| Klinikum Bremen-Ost gGmbH | Bremen | Germany | |
| Klinik Schillerhoehe | Gerlingen | Germany | |
| Katholisches Klinikum Koblenz | Koblenz | Germany |