Clinical trial NCT01467622: Effects of Local Protocols on Duration of Chest Tube Therapy Following Thoracic Surgery
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Air Leak
Keywords: chest tube drainage
pulmonary air leak
lung resection
Lead sponsor: Schillerhoehe Hospital
Sponsor class: OTHER
Collaborators: name: Medela AG
First posted: 2011-11-09
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients undergoing pulmonary resection at one of the four participating thoracic surgery specialist units

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.

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 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

Primary outcomes:
measure: chest tube therapy duration
timeFrame: participants are followed for the duration of hospital stay, an expected average of 5 days
Secondary outcomes:
measure: presence of pulmonary air leak
timeFrame: participants are followed for the duration of hospital stay, an expected average of 4 days
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Evangelische Lungenklinik Berlin
city: Bremen
country: Germany
facility: Klinikum Bremen-Ost gGmbH
city: Gerlingen
country: Germany
facility: Klinik Schillerhoehe
city: Koblenz
country: Germany
facility: Katholisches Klinikum Koblenz
Study officials:
affiliation: Klinikum Bremen-Ost gGmbH
name: Albert Linder, MD
role: STUDY_DIRECTOR
affiliation: Schillerhoehe Hospital
name: Thorsten Walles, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medela GmbH & Co. Handels KG
name: Josef Wolf
role: STUDY_CHAIR
References:
citation: 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.