Effects of Local Protocols on Duration of Chest Tube Therapy Following Thoracic Surgery

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: NCT01467622
Recruitment Status : Completed
First Posted : November 9, 2011
Last Update Posted : May 7, 2013
Medela AG
Information provided by (Responsible Party):
Thorsten Walles, Schillerhoehe Hospital

Brief Summary:
The effect of local chest-tube management protocols on the duration of chest-tube therapy following thoracic surgery was analyzed in four German specialized Thoracic Surgery Units. The primary study objective was the duration of chest tube therapy in postoperative patients.

Condition or disease Intervention/treatment
Pulmonary Air Leak Procedure: Chest tube removal

Detailed Description:
The management of chest tubes is probably one of the most critical aspects in patient care in thoracic surgery and defines the required length of postoperative hospital stay in the majority of patients. So far, no generally accepted recommendations exist for postoperative chest tube management to streamline the postoperative stay. Instead, decision making in most thoracic surgery units is based on team preferences and individual training rather than scientific data. Therefore, digital pleural drainage systems represent a useful tool to standardize existing intradepartmental protocols for chest tube management. However, for the development of generally accepted protocol-recommendations, the diverging interdepartmental treatment protocols have to be analyzed and compared for superiority. In this IIT, the effect of different chest tube management protocols on chest tube duration is analyzed in four German Thoracic Surgery units.

Study Type : Observational
Actual Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective, Non Randomized Investigator Initiated Multi-centre Trial on the Effects of Local Treatment Protocols on the Duration of Chest Tube Therapy Following Thoracic Surgery in Germany
Study Start Date : April 2009
Actual Primary Completion Date : August 2009
Actual Study Completion Date : October 2011

Group/Cohort Intervention/treatment
Study population
Patients undergoing elective pulmonary wedge resection, anatomic segmentectomy, or lobectomy.
Procedure: Chest tube removal
Chest tube removal on the basis of local recommendations for postoperative chest tube management

Primary Outcome Measures :
  1. chest tube therapy duration [ Time Frame: participants are followed for the duration of hospital stay, an expected average of 5 days ]
    number of days following thoracic surgery until chest tube was removed

Secondary Outcome Measures :
  1. presence of pulmonary air leak [ Time Frame: participants are followed for the duration of hospital stay, an expected average of 4 days ]
    number of days the Medela Thopaz device detected a pulmonary air leak following thoracic surgery

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients undergoing pulmonary resection at one of the four participating thoracic surgery specialist units

Inclusion Criteria:

  • age 18-85
  • following pulmonary wedge resection, anatomic segmentectomy, or lobectomy

Exclusion Criteria:

  • surgery for spontaneous pneumothorax (primary and secondary)
  • surgery for pleural empyema
  • present medication with corticoids, immunosuppressive drugs or platelet aggregation inhibitors other than Aspirin
  • history of chemotherapy, radiotherapy of the chest, or previous ipsilateral thoracic surgery

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): NCT01467622

Evangelische Lungenklinik Berlin
Berlin, Germany, 13125
Klinikum Bremen-Ost gGmbH
Bremen, Germany, 28325
Klinik Schillerhoehe
Gerlingen, Germany, 70839
Katholisches Klinikum Koblenz
Koblenz, Germany, 56073
Sponsors and Collaborators
Schillerhoehe Hospital
Medela AG
Study Director: Albert Linder, MD Klinikum Bremen-Ost gGmbH
Principal Investigator: Thorsten Walles, MD Schillerhoehe Hospital
Study Chair: Josef Wolf Medela GmbH & Co. Handels KG

Publications of Results:
Responsible Party: Thorsten Walles, Prinicpal Investigator, Schillerhoehe Hospital Identifier: NCT01467622     History of Changes
Other Study ID Numbers: KSH-TCH-IIT-2009-1
First Posted: November 9, 2011    Key Record Dates
Last Update Posted: May 7, 2013
Last Verified: May 2013

Keywords provided by Thorsten Walles, Schillerhoehe Hospital:
chest tube drainage
pulmonary air leak
lung resection