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

Sponsor

University of Ulm (Other)

Overall Status

Unknown status

CT.gov ID

NCT00530491

Collaborator

Heidelberg University (Other)

Enrollment

Location

Arms

Duration (Months)

6.9

Patients Per Site Per Month

Study Details

Study Description

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	N/A

Study Design

Study Type:

Interventional

Anticipated 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 :

Sep 1, 2007

Anticipated Primary Completion Date :

Sep 1, 2008

Anticipated Study Completion Date :

Oct 1, 2008

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

pulmonary complications (air leak, atelectasis, pneumonia); lung function on pod 7; overall mortality [1 year]

Secondary Outcome Measures

duration of ICU treatment [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	University of Ulm	Ulm		Germany	89075

Sponsors and Collaborators

University of Ulm
Heidelberg University

Investigators

Study Chair: Bernd M Muehling, M.D.,

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00530491

Other Study ID Numbers:

BM 140/07

First Posted:

Sep 17, 2007

Last Update Posted:

Feb 14, 2008

Last Verified:

Sep 1, 2007

Keywords provided by , ,

lung resection

reduced pulmonary function

Additional relevant MeSH terms:

Respiration Disorders

Study Results

No Results Posted as of Feb 14, 2008