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Prospective Trial to Reduce Morbidity and Mortality After Lung Surgery in Patients With Reduced Pulmonary Capacity

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ClinicalTrials.gov Identifier: NCT00530491
Recruitment Status : Unknown
Verified September 2007 by University of Ulm.
Recruitment status was:  Recruiting
First Posted : September 17, 2007
Last Update Posted : February 14, 2008
Sponsor:
Collaborator:
Heidelberg University
Information provided by:
University of Ulm

Brief Summary:
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 or disease Intervention/treatment Phase
Respiration Disorders Procedure: Fast track lung surgery Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : September 2007
Estimated Primary Completion Date : September 2008
Estimated Study Completion Date : October 2008

Arm Intervention/treatment
Active Comparator: 1
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

Experimental: 2
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




Primary Outcome Measures :
  1. pulmonary complications (air leak, atelectasis, pneumonia); lung function on pod 7; overall mortality [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. duration of ICU treatment [ Time Frame: 1 year ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • resection of the lung
  • FEV1 <70% of expected value or below 1.5L
  • 18-80y
  • given written informed consent

Exclusion Criteria:

  • contraindication for epidural anesthesia
  • prio ipsilateral thoracotomy
  • chemotherapy <6 weeks prior to study enter
  • existing pneumonia (fever, elevated WCC, elevated CRP)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00530491


Contacts
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

Locations
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.         
Sponsors and Collaborators
University of Ulm
Heidelberg University
Investigators
Study Chair: Bernd M Muehling, M.D.

Responsible Party: Bernd Muehling, M.D., Dep. of Thoracic and Vascular Surgery, University of Ulm , Germany
ClinicalTrials.gov Identifier: NCT00530491     History of Changes
Other Study ID Numbers: BM 140/07
First Posted: September 17, 2007    Key Record Dates
Last Update Posted: February 14, 2008
Last Verified: September 2007

Keywords provided by University of Ulm:
lung resection
reduced pulmonary function

Additional relevant MeSH terms:
Respiration Disorders
Respiratory Tract Diseases