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

NCT01177215 | Terminated DMC

• 1 other identifier: GE-ADAPTALGO-2010
• Study Type: observational
• Target: 39
• Locations: 1 country
• Sites: 4

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.

Conditions

Pulmonary Fistula

Keywords

Algorithm; Treatment Protocol; Thoracic Drainage Device

Outcome Measures

Primary Outcomes (1)

• Duration of pulmo-pleural fistulation

  The duration of a postoperative pulmo-pleural fistula is monitored.

  July 2011 - March 2012

Secondary Outcomes (2)

• Duration of Chest tube therapy

  July 2011 - March 2012

• Applicability of a diagnostic "Leakage Scale"

  July 2011 - March 2012

Study Arms (1)

Digital chest tube

All patients will be treated with the digital chest tube device

Procedure: Thoracic Surgery

Interventions

Thoracic Surgery PROCEDURE

Wedge Resection Segmental Resection Lobectomy

Also known as: Thopaz Drainage Device

Digital chest tube

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Thoracic Surgery Patient

You may qualify if:

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

You may not qualify if:

• Patients with an empyema
• Patients with a spontaneous pneumothorax

Sponsors & Collaborators

• Medela AG: lead

Study Sites (4)

Klinikum Bremen-Ost

Bremen, City state Bremen, 28325, Germany

Location

Klinik Schillerhöhe

Gerlingen, Gerlingen, 70839, Germany

Location

Universitätsklinik Freiburg

Freiburg im Breisgau, 79106, Germany

Location

Krankenhaus Großhansdorf

Großhansdorf, 22927, Germany

Location

Related 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. doi: 10.1016/s0003-4975(03)00884-1.

  PMID: 14529982 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.

  PMID: 12806240 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.

  PMID: 16122484 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.

  PMID: 18640304 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.

  PMID: 18848460 BACKGROUND

MeSH Terms

Interventions

Thoracic Surgical Procedures

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

• Thorsten Walles, MD FETCS

  Schillerhoehe Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study Director

Study Record Dates

• First Submitted: August 4, 2010
• First Posted: August 6, 2010
• Study Start: July 1, 2011
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: May 7, 2013

Record last verified: 2013-05

Locations

DE (4)