NCT00530491

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2007

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

September 13, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 17, 2007

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
Last Updated

February 14, 2008

Status Verified

September 1, 2007

Enrollment Period

1 year

First QC Date

September 13, 2007

Last Update Submit

February 1, 2008

Conditions

Respiration Disorders

Keywords

lung resectionreduced pulmonary function

Outcome Measures

Primary Outcomes (1)

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

    1 year

Secondary Outcomes (1)

  • duration of ICU treatment

    1 year

Study Arms (2)

1

ACTIVE COMPARATOR

conventional perioperative management for lung surgery

Procedure: Fast track lung surgery

2

EXPERIMENTAL

fast track management for lung surgery

Procedure: Fast track lung surgery

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

12

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • resection of the lung
  • FEV1 \<70% of expected value or below 1.5L
  • given written informed consent

You may not qualify if:

  • contraindication for epidural anesthesia
  • prio ipsilateral thoracotomy
  • chemotherapy \<6 weeks prior to study enter
  • existing pneumonia (fever, elevated WCC, elevated CRP)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Ulm

Ulm, 89075, Germany

RECRUITING

MeSH Terms

Conditions

Respiration Disorders

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

  • Bernd M Muehling, M.D.

    STUDY CHAIR

Central Study Contacts

Bernd M Muehling, M.D.

CONTACT

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

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

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2007

First Posted

September 17, 2007

Study Start

September 1, 2007

Primary Completion

September 1, 2008

Study Completion

October 1, 2008

Last Updated

February 14, 2008

Record last verified: 2007-09

Locations

DE(1)