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

This study has been terminated.

(Interim analysis showed that the tested protocol did not improve treatment)

Sponsor:

Information provided by (Responsible Party):

Inez Cregan, Medela AG

ClinicalTrials.gov Identifier:

NCT01177215

First received: August 4, 2010

Last updated: May 5, 2013

Last verified: May 2013

History of Changes

Purpose

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.

Condition	Intervention
Pulmonary Fistula	Procedure: Thoracic Surgery

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Implementation of an Adaptive Algorithm to Improve Chest Tube Therapy in Patients With Pulmonary Leaks Following Thoracic Surgery

Resource links provided by NLM:

MedlinePlus related topics: Alpha-1 Antitrypsin Deficiency Fistulas

U.S. FDA Resources

Further study details as provided by Medela AG:

Primary Outcome Measures:

Duration of pulmo-pleural fistulation [ Time Frame: July 2011 - March 2012 ] [ Designated as safety issue: No ]
The duration of a postoperative pulmo-pleural fistula is monitored.

Secondary Outcome Measures:

Duration of Chest tube therapy [ Time Frame: July 2011 - March 2012 ] [ Designated as safety issue: No ]
Duration of postoperative chest tube therapy is monitored.
Applicability of a diagnostic "Leakage Scale" [ Time Frame: July 2011 - March 2012 ] [ Designated as safety issue: No ]
Applicability of a generated scale that categorizes the pulmonary air leak is tested.

Enrollment:	39
Study Start Date:	July 2011
Study Completion Date:	November 2012
Primary Completion Date:	November 2012 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Digital chest tube All patients will be treated with the digital chest tube device	Procedure: Thoracic Surgery Wedge Resection Segmental Resection Lobectomy Other Name: Thopaz Drainage Device

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Thoracic Surgery Patient

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01177215

Locations

Germany
Klinikum Bremen-Ost
Bremen, Germany, 28325
Universitätsklinik Freiburg
Freiburg, Germany, 79106
Klinik Schillerhöhe
Gerlingen, Germany, 70839
Krankenhaus Großhansdorf
Großhansdorf, Germany, 22927

Sponsors and Collaborators

Medela AG

Investigators

Principal Investigator:

Thorsten Walles, MD FETCS

Schillerhoehe Hospital

More Information

Publications:

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.

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.

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.

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.

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. Epub 2008 Oct 9.

Responsible Party:	Inez Cregan, Study Director, Medela AG
ClinicalTrials.gov Identifier:	NCT01177215 History of Changes
Other Study ID Numbers:	GE-ADAPTALGO-2010
Study First Received:	August 4, 2010
Last Updated:	May 5, 2013
Health Authority:	Germany: Ethics Commission

Keywords provided by Medela AG:

Algorithm
Treatment Protocol
Thoracic Drainage Device

Additional relevant MeSH terms:

Fistula
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on May 21, 2013

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