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
  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:


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:
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 April 17, 2014