Investigation of an Adaptive Treatment Algorithm for Post-op Thoracic Patients to Reduce the Length of Drainage

Pulmonary Fistula Clinical Trial

— AATD  

Official title:

Implementation of an Adaptive Algorithm to Improve Chest Tube Therapy in Patients With Pulmonary Leaks Following Thoracic Surgery

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01177215
• Other study ID #: GE-ADAPTALGO-2010
• Status: Terminated
• Phase: N/A
• First received: August 4, 2010
• Last updated: May 5, 2013
• Start date: July 2011
• Est. completion date: November 2012

Study information

• Verified date: May 2013
• Source: Medela AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 39
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pulmonary Fistula

Intervention

Procedure:
• Thoracic Surgery
Wedge Resection Segmental Resection Lobectomy

Locations

Country	Name	City	State
Germany	Klinikum Bremen-Ost	Bremen
Germany	Universitätsklinik Freiburg	Freiburg
Germany	Klinik Schillerhöhe	Gerlingen
Germany	Krankenhaus Großhansdorf	Großhansdorf

Sponsors (1)

Lead Sponsor	Collaborator
Medela AG

Country where clinical trial is conducted

Germany, 

References & Publications (5)

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. — View 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. Review. — View 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. — View 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. — View Citation

Varela G, Jiménez 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of pulmo-pleural fistulation	The duration of a postoperative pulmo-pleural fistula is monitored.	July 2011 - March 2012	No
Secondary	Duration of Chest tube therapy	Duration of postoperative chest tube therapy is monitored.	July 2011 - March 2012	No
Secondary	Applicability of a diagnostic "Leakage Scale"	Applicability of a generated scale that categorizes the pulmonary air leak is tested.	July 2011 - March 2012	No