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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00530491
Other study ID # BM 140/07
Secondary ID
Status Recruiting
Phase N/A
First received September 13, 2007
Last updated February 1, 2008
Start date September 2007
Est. completion date October 2008

Study information

Verified date September 2007
Source University of Ulm
Contact Bernd M Muehling, M.D.
Phone +49-731-500
Email bernd.muehling@uniklinik-ulm.de
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 90
Est. completion date October 2008
Est. primary completion date September 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility 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)

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Germany University of Ulm Ulm

Sponsors (2)

Lead Sponsor Collaborator
University of Ulm Heidelberg University

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary pulmonary complications (air leak, atelectasis, pneumonia); lung function on pod 7; overall mortality 1 year Yes
Secondary duration of ICU treatment 1 year Yes
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