Effects of Local Protocols on Duration of Chest Tube Therapy Following Thoracic Surgery
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
1 other identifier
observational
80
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Apr 2009
Typical duration for all trials
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2011
CompletedFirst Submitted
Initial submission to the registry
October 30, 2011
CompletedFirst Posted
Study publicly available on registry
November 9, 2011
CompletedMay 7, 2013
May 1, 2013
4 months
October 30, 2011
May 6, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
chest tube therapy duration
number of days following thoracic surgery until chest tube was removed
participants are followed for the duration of hospital stay, an expected average of 5 days
Secondary Outcomes (1)
presence of pulmonary air leak
participants are followed for the duration of hospital stay, an expected average of 4 days
Study Arms (1)
Study population
Patients undergoing elective pulmonary wedge resection, anatomic segmentectomy, or lobectomy.
Interventions
Chest tube removal on the basis of local recommendations for postoperative chest tube management
Eligibility Criteria
patients undergoing pulmonary resection at one of the four participating thoracic surgery specialist units
You may qualify if:
- age 18-85
- following pulmonary wedge resection, anatomic segmentectomy, or lobectomy
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Schillerhoehe Hospitallead
- Medela AGcollaborator
Study Sites (4)
Evangelische Lungenklinik Berlin
Berlin, 13125, Germany
Klinikum Bremen-Ost gGmbH
Bremen, 28325, Germany
Klinik Schillerhoehe
Gerlingen, 70839, Germany
Katholisches Klinikum Koblenz
Koblenz, 56073, Germany
Related Publications (1)
Linder A, Ertner C, Steger V, Messerschmidt A, Merk J, Cregan I, Timm J, Walles T. Postoperative chest tube management: snapshot of German diversity. Interact Cardiovasc Thorac Surg. 2012 Oct;15(4):622-6. doi: 10.1093/icvts/ivs270. Epub 2012 Jun 29.
PMID: 22753431RESULT
Study Officials
- 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
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prinicpal Investigator
Study Record Dates
First Submitted
October 30, 2011
First Posted
November 9, 2011
Study Start
April 1, 2009
Primary Completion
August 1, 2009
Study Completion
October 1, 2011
Last Updated
May 7, 2013
Record last verified: 2013-05