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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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