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

Sponsors and Collaborators:	University of Ulm University of Heidelberg
Information provided by:	University of Ulm
ClinicalTrials.gov Identifier:	NCT00530491

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

Drug Information available for: X-Rays

U.S. FDA Resources

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

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
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

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

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

University of Heidelberg

Investigators

Study Chair:

Bernd M Muehling, M.D.

unaffiliated

More Information

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

Keywords provided by University of Ulm:

lung resection
reduced pulmonary function

Study placed in the following topic categories:

Respiratory Tract Diseases
Respiration Disorders

ClinicalTrials.gov processed this record on January 16, 2009