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Sponsors and Collaborators: |
University of Ulm University of Heidelberg |
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Information provided by: | University of Ulm |
ClinicalTrials.gov Identifier: | NCT00530491 |
A fast track recovery program (thoracic epidural anesthesia, carbohydrate drink preoperative, early removal of chest tubes) is evaluated compared to conventional perioperative treatment (patient controlled analgesia, no carbohydrate drink preoperative) in patients with FEV1 < 70% of expected value or < 1.5L who undergo resections of the lung.
Condition | Intervention |
---|---|
Respiration Disorders |
Procedure: Fast track lung surgery |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment |
Official Title: | Prospective Randomized Controlled Trial to Reduce Morbidity and Mortality After Lung Surgery in Patients With FEV1 < 70% of Expected Value or < 1.5L |
Estimated Enrollment: | 90 |
Study Start Date: | September 2007 |
Estimated Study Completion Date: | October 2008 |
Estimated Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Active Comparator
conventional perioperative management for lung surgery
|
Procedure: Fast track lung surgery
fast track lung surgery: carbohydrate drink preoperatively, PCEA, early removal of chest tube conventional: no carbohydrate drink preoperatively, ICB+PCA, removal of chest tube depending upon chest x-ray
|
2: Experimental
fast track management for lung surgery
|
Procedure: Fast track lung surgery
fast track lung surgery: carbohydrate drink preoperatively, PCEA, early removal of chest tube conventional: no carbohydrate drink preoperatively, ICB+PCA, removal of chest tube depending upon chest x-ray
|
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Bernd M Muehling, M.D. | +49-731-500 ext 54044 | bernd.muehling@uniklinik-ulm.de |
Contact: Karl-Heinz Orend, M.D., Ph.D. | +49-731-500 ext 54005 | karl-heinz.orend@uniklinik-ulm.de |
Germany | |
University of Ulm | Recruiting |
Ulm, Germany, 89075 | |
Contact: Bernd M Muehling, M.D. +49-731-500 ext 54055 bernd.muehling@uniklinik-ulm.de | |
Contact: Alexander Oberhuber, M.D. +49-731-500 ext 54058 alexander.oberhuber@uniklinik-ulm.de | |
Principal Investigator: Bernd M Muheling, M.D. |
Study Chair: | Bernd M Muehling, M.D. | unaffiliated |
Responsible Party: | Dep. of Thoracic and Vascular Surgery, University of Ulm , Germany ( Bernd Muehling, M.D. ) |
Study ID Numbers: | BM 140/07 |
Study First Received: | September 13, 2007 |
Last Updated: | February 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00530491 |
Health Authority: | Germany: Ethics Commission |
lung resection reduced pulmonary function |
Respiratory Tract Diseases Respiration Disorders |