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

University of Ulm90 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Respiration Disorders

Interventions

Fast track lung surgeryPROCEDURE

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

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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)

Locations (1)

University of Ulm

Ulm, Germany

RECRUITING

Outcomes

Primary Outcomes

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

Time frame: 1 year

Secondary Outcomes

duration of ICU treatment

Time frame: 1 year

Central Contacts

Bernd M Muehling, M.D.

CONTACT

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

Karl-Heinz Orend, M.D., Ph.D.

CONTACT

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

Data from ClinicalTrials.gov

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