Clinical trial NCT01177215: Investigation of an Adaptive Treatment Algorithm for Post-op Thoracic Patients to Reduce the Length of Drainage
Official title: Implementation of an Adaptive Algorithm to Improve Chest Tube Therapy in Patients With Pulmonary Leaks Following Thoracic Surgery
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Pulmonary Fistula
Keywords: Algorithm
Treatment Protocol
Thoracic Drainage Device
Lead sponsor: Medela AG
Sponsor class: INDUSTRY
First posted: 2010-08-06
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Thoracic Surgery Patient

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Patients with a post operative air leak after 16 to 24 hours bigger than 50ml/min.

Exclusion Criteria:

* Patients with an empyema
* Patients with a spontaneous pneumothorax

Primary outcomes:
measure: Duration of pulmo-pleural fistulation
timeFrame: July 2011 - March 2012
Secondary outcomes:
measure: Duration of Chest tube therapy
timeFrame: July 2011 - March 2012
measure: Applicability of a diagnostic "Leakage Scale"
timeFrame: July 2011 - March 2012
Other outcomes:
Locations:
city: Bremen
country: Germany
facility: Klinikum Bremen-Ost
city: Freiburg
country: Germany
facility: Universitätsklinik Freiburg
city: Gerlingen
country: Germany
facility: Klinik Schillerhöhe
city: Großhansdorf
country: Germany
facility: Krankenhaus Großhansdorf
Study officials:
affiliation: Schillerhoehe Hospital
name: Thorsten Walles, MD FETCS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.