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

May 5, 2013 updated by: Inez Cregan, Medela AG

Implementation of an Adaptive Algorithm to Improve Chest Tube Therapy in Patients With Pulmonary Leaks Following Thoracic Surgery

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Enrollment (Actual)

39

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Thoracic Surgery Patient

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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 Names:
  • Thopaz Drainage Device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of pulmo-pleural fistulation
Time Frame: July 2011 - March 2012
The duration of a postoperative pulmo-pleural fistula is monitored.
July 2011 - March 2012

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of Chest tube therapy
Time Frame: July 2011 - March 2012
Duration of postoperative chest tube therapy is monitored.
July 2011 - March 2012
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.
July 2011 - March 2012

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medela AG

Investigators

  • Principal Investigator: Thorsten Walles, MD FETCS, Schillerhoehe Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (Actual)

November 1, 2012

Study Completion (Actual)

November 1, 2012

Study Registration Dates

First Submitted

August 4, 2010

First Submitted That Met QC Criteria

August 5, 2010

First Posted (Estimate)

August 6, 2010

Study Record Updates

Last Update Posted (Estimate)

May 7, 2013

Last Update Submitted That Met QC Criteria

May 5, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GE-ADAPTALGO-2010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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