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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2007 by University of Ulm.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Heidelberg University
Information provided by:
University of Ulm
ClinicalTrials.gov Identifier:
NCT00530491
First received: September 13, 2007
Last updated: February 1, 2008
Last verified: September 2007
  Purpose

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: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Further study details as provided by University of Ulm:

Primary Outcome Measures:
  • pulmonary complications (air leak, atelectasis, pneumonia); lung function on pod 7; overall mortality [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • duration of ICU treatment [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

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
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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.
  More Information

No publications provided

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
Study First Received: September 13, 2007
Last Updated: February 1, 2008
Health Authority: Germany: Ethics Commission

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

Additional relevant MeSH terms:
Respiration Disorders
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 20, 2014