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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01177215
Recruitment Status : Terminated (Interim analysis showed that the tested protocol did not improve treatment)
First Posted : August 6, 2010
Last Update Posted : May 7, 2013
Information provided by (Responsible Party):
Inez Cregan, Medela AG

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.

Condition or disease Intervention/treatment
Pulmonary Fistula Procedure: Thoracic Surgery

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.

Study Type : Observational
Actual Enrollment : 39 participants
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
Study Start Date : July 2011
Actual Primary Completion Date : November 2012
Actual Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fistulas

Group/Cohort Intervention/treatment
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

Primary Outcome Measures :
  1. Duration of pulmo-pleural fistulation [ Time Frame: July 2011 - March 2012 ]
    The duration of a postoperative pulmo-pleural fistula is monitored.

Secondary Outcome Measures :
  1. Duration of Chest tube therapy [ Time Frame: July 2011 - March 2012 ]
    Duration of postoperative chest tube therapy is monitored.

  2. Applicability of a diagnostic "Leakage Scale" [ Time Frame: July 2011 - March 2012 ]
    Applicability of a generated scale that categorizes the pulmonary air leak is tested.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Thoracic Surgery Patient

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01177215

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
Principal Investigator: Thorsten Walles, MD FETCS Schillerhoehe Hospital

Responsible Party: Inez Cregan, Study Director, Medela AG Identifier: NCT01177215     History of Changes
Other Study ID Numbers: GE-ADAPTALGO-2010
First Posted: August 6, 2010    Key Record Dates
Last Update Posted: May 7, 2013
Last Verified: May 2013

Keywords provided by Inez Cregan, Medela AG:
Treatment Protocol
Thoracic Drainage Device

Additional relevant MeSH terms:
Pathological Conditions, Anatomical