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

NCT ID: NCT00530491

Last Updated: 2008-02-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2008-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Respiration Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

conventional perioperative management for lung surgery

Group Type ACTIVE_COMPARATOR

Fast track lung surgery

Intervention Type PROCEDURE

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

2

fast track management for lung surgery

Group Type EXPERIMENTAL

Fast track lung surgery

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type PROCEDURE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Heidelberg University

OTHER

Sponsor Role collaborator

University of Ulm

OTHER

Sponsor Role lead

Responsible Party

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Dep. of Thoracic and Vascular Surgery, University of Ulm , Germany

Principal Investigators

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Bernd M Muehling, M.D.

Role: STUDY_CHAIR

Locations

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University of Ulm

Ulm, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Bernd M Muehling, M.D.

Role: CONTACT

+49-731-500 ext. 54044

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

Role: CONTACT

+49-731-500 ext. 54005

Facility Contacts

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Bernd M Muehling, M.D.

Role: primary

+49-731-500 ext. 54055

Alexander Oberhuber, M.D.

Role: backup

+49-731-500 ext. 54058

Other Identifiers

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BM 140/07

Identifier Type: -

Identifier Source: org_study_id

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