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

Prospective Randomized Controlled Trial to Reduce Morbidity and Mortality After Lung Surgery in Patients With FEV1 < 70% of Expected Value or < 1.5L

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00530491

Enrollment

Registered

2007-09-17

Start date

2007-09-30

Completion date

2008-10-31

Last updated

2008-02-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiration Disorders

Keywords

lung resection, reduced pulmonary function

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.

Interventions

PROCEDUREFast 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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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)

Design outcomes

Primary

Measure	Time frame
pulmonary complications (air leak, atelectasis, pneumonia); lung function on pod 7; overall mortality	1 year

Secondary

Measure	Time frame
duration of ICU treatment	1 year

Countries

Germany

Contacts

Primary ContactBernd M Muehling, M.D.

bernd.muehling@uniklinik-ulm.de+49-731-500

Backup ContactKarl-Heinz Orend, M.D., Ph.D.

karl-heinz.orend@uniklinik-ulm.de+49-731-500

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026