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

Respiration Disorders Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00530491
• Other study ID #: BM 140/07
• 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

• Respiration Disorders

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