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

Pulmonary Air Leak Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01467622
• Other study ID #: KSH-TCH-IIT-2009-1
• Status: Completed
• Phase: N/A
• First received: October 30, 2011
• Last updated: May 6, 2013
• Start date: April 2009
• Est. completion date: October 2011

Study information

• Verified date: May 2013
• Source: Schillerhoehe Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: October 2011
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pulmonary Air Leak

Intervention

Procedure:
• Chest tube removal
Chest tube removal on the basis of local recommendations for postoperative chest tube management

Locations

Country	Name	City	State
Germany	Evangelische Lungenklinik Berlin	Berlin
Germany	Klinikum Bremen-Ost gGmbH	Bremen
Germany	Klinik Schillerhoehe	Gerlingen
Germany	Katholisches Klinikum Koblenz	Koblenz

Sponsors (2)

Lead Sponsor	Collaborator
Schillerhoehe Hospital	Medela AG

Country where clinical trial is conducted

Germany, 

References & 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. Epub 2012 Jun 29. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	presence of pulmonary air leak	number of days the Medela Thopaz device detected a pulmonary air leak following thoracic surgery	participants are followed for the duration of hospital stay, an expected average of 4 days	No