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

This study has been completed.
Sponsor:
Collaborator:
Medela AG
Information provided by (Responsible Party):
Thorsten Walles, Schillerhoehe Hospital
ClinicalTrials.gov Identifier:
NCT01467622
First received: October 30, 2011
Last updated: May 6, 2013
Last verified: May 2013
  Purpose

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 Intervention
Pulmonary Air Leak
Procedure: Chest tube removal

Study Type: Observational
Study Design: 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

Further study details as provided by Schillerhoehe Hospital:

Primary Outcome Measures:
  • chest tube therapy duration [ Time Frame: participants are followed for the duration of hospital stay, an expected average of 5 days ] [ Designated as safety issue: No ]
    number of days following thoracic surgery until chest tube was removed


Secondary Outcome Measures:
  • presence of pulmonary air leak [ Time Frame: participants are followed for the duration of hospital stay, an expected average of 4 days ] [ Designated as safety issue: No ]
    number of days the Medela Thopaz device detected a pulmonary air leak following thoracic surgery


Enrollment: 80
Study Start Date: April 2009
Study Completion Date: October 2011
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01467622

Locations
Germany
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
Investigators
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
  More Information

Publications:
Responsible Party: Thorsten Walles, Prinicpal Investigator, Schillerhoehe Hospital
ClinicalTrials.gov Identifier: NCT01467622     History of Changes
Other Study ID Numbers: KSH-TCH-IIT-2009-1
Study First Received: October 30, 2011
Last Updated: May 6, 2013
Health Authority: Germany: Ethics Commission

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

ClinicalTrials.gov processed this record on April 16, 2014