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

Terminated

• Conditions: Pulmonary Fistula
• Interventions: Procedure: Thoracic Surgery

• Registration Number: NCT01177215
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2010-08-04
• Study First Submitted QC: 2010-08-05
• Study First Posted: 2010-08-06
• Study Start: 2011-07
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-05
• Last Update Posted: 2013-05-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 39

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Digital chest tube	Thoracic Surgery	All patients will be treated with the digital chest tube device

Primary Outcome Measures

Name	Time	Method
Duration of pulmo-pleural fistulation	July 2011 - March 2012	The duration of a postoperative pulmo-pleural fistula is monitored.

Secondary Outcome Measures

Name	Time	Method
Duration of Chest tube therapy	July 2011 - March 2012	Duration of postoperative chest tube therapy is monitored.
Applicability of a diagnostic "Leakage Scale"	July 2011 - March 2012	Applicability of a generated scale that categorizes the pulmonary air leak is tested.

Trial Locations

Locations (4)

Klinik Schillerhöhe; 🇩🇪 Gerlingen, Germany

Universitätsklinik Freiburg; 🇩🇪 Freiburg, Germany

Klinikum Bremen-Ost; 🇩🇪 Bremen, Germany

Krankenhaus Großhansdorf; 🇩🇪 Großhansdorf, Germany