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Interim analysis showed that the tested protocol did not improve treatment
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The purpose of this study is to reduce the length of drainage using a treatment protocol to control the manipulation of the applied vacuum to the pleural cavity.
In this prospective study, a treatment algorithm is tested in a subgroup of patients with postoperative pulmo-pleural fistula. The primary aim is to reduce the duration of pulmo-pleural fistulation. Secondary aim is to reduce the duration of chest tube therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Digital chest tube | All patients will be treated with the digital chest tube device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thoracic Surgery | Procedure | Wedge Resection Segmental Resection Lobectomy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Duration of pulmo-pleural fistulation | The duration of a postoperative pulmo-pleural fistula is monitored. | July 2011 - March 2012 |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Chest tube therapy | Duration of postoperative chest tube therapy is monitored. | July 2011 - March 2012 |
| Applicability of a diagnostic "Leakage Scale" | Applicability of a generated scale that categorizes the pulmonary air leak is tested. |
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Inclusion Criteria:
Exclusion Criteria:
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Thoracic Surgery Patient
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| Name | Affiliation | Role |
|---|---|---|
| Thorsten Walles, MD FETCS | Schillerhoehe Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinikum Bremen-Ost | Bremen | Free Hanseatic City of Bremen | 28325 | Germany | ||
| Klinik Schillerhöhe |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14529982 | Background | Alex J, Ansari J, Bahalkar P, Agarwala S, Rehman MU, Saleh A, Cowen ME. Comparison of the immediate postoperative outcome of using the conventional two drains versus a single drain after lobectomy. Ann Thorac Surg. 2003 Oct;76(4):1046-9. doi: 10.1016/s0003-4975(03)00884-1. | |
| 12806240 | Background | Baumann MH. What size chest tube? What drainage system is ideal? And other chest tube management questions. Curr Opin Pulm Med. 2003 Jul;9(4):276-81. doi: 10.1097/00063198-200307000-00006. |
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| ID | Term |
|---|---|
| D019616 | Thoracic Surgical Procedures |
| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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| July 2011 - March 2012 |
| Gerlingen |
| Gerlingen |
| 70839 |
| Germany |
| Universitätsklinik Freiburg | Freiburg im Breisgau | 79106 | Germany |
| Krankenhaus Großhansdorf | Großhansdorf | 22927 | Germany |
| 16122484 | Background | Brunelli A, Sabbatini A, Xiume' F, Refai MA, Salati M, Marasco R. Alternate suction reduces prolonged air leak after pulmonary lobectomy: a randomized comparison versus water seal. Ann Thorac Surg. 2005 Sep;80(3):1052-5. doi: 10.1016/j.athoracsur.2005.03.073. |
| 18640304 | Background | Cerfolio RJ, Bryant AS. The benefits of continuous and digital air leak assessment after elective pulmonary resection: a prospective study. Ann Thorac Surg. 2008 Aug;86(2):396-401. doi: 10.1016/j.athoracsur.2008.04.016. |
| 18848460 | Background | Varela G, Jimenez MF, Novoa NM, Aranda JL. Postoperative chest tube management: measuring air leak using an electronic device decreases variability in the clinical practice. Eur J Cardiothorac Surg. 2009 Jan;35(1):28-31. doi: 10.1016/j.ejcts.2008.09.005. Epub 2008 Oct 9. |