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

NCT01467622 — Completed, 80 participants, Schillerhoehe Hospital

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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

RegistryNCT01467622
StatusCompleted
Study typeObservational
Enrollment80 (Actual)
SponsorSchillerhoehe Hospital (Other); collaborators: Medela AG
ConditionsPulmonary Air Leak
InterventionsChest tube removal (Procedure)
Datesstart 2009-04-01, primary completion 2009-08-01, completion 2011-10-01, first posted 2011-11-09, last updated 2013-05-07
Locations4 sites in Germany

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-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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
Study populationProcedure: Chest tube removalPatients undergoing elective pulmonary wedge resection, anatomic segmentectomy, or lobectomy.
  • Chest tube removal (Procedure): Chest tube removal on the basis of local recommendations for postoperative chest tube management

+Outcome measures

Primary outcomes

  • chest tube therapy duration [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 outcomes

  • presence of pulmonary air leak [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

+Eligibility

Sex: All, ages: 18 Years to 85 Years

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

+Locations (4)

FacilityCityCountryStatus
Evangelische Lungenklinik BerlinBerlinGermany
Klinikum Bremen-Ost gGmbHBremenGermany
Klinik SchillerhoeheGerlingenGermany
Katholisches Klinikum KoblenzKoblenzGermany

+Publications

  • Results publication: 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 22753431

+Investigators

My Notes