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Clinical Trials/NCT00167622
NCT00167622
Completed
Phase 2

Efficacy and Safety of Preventive Mechanical Ventilation in Adults With Guillain Barré Syndrome

University of Versailles1 site in 1 country50 target enrollmentApril 2005

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Guillain Barré Syndrome
Sponsor
University of Versailles
Enrollment
50
Locations
1
Primary Endpoint
Rate of hospital acquired pneumonia from randomization to study day 90
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

The purpose of this study is to determine whether early mechanical ventilation can prevent hospital acquired pneumonia in adults with Guillain Barré Syndrome.

Detailed Description

Hospital acquired pneumonia is a common and severe complication of Guillain Barré Syndrome. Several factors have been recognized as predictors of respiratory failure in adults with Guillain Barré Syndrome. They include a time from disease onset and patient admission of less seven days, inability to lift head, impaired swallowing and a forced vital capacity of less than 60% of predictive value. We reasonned that early mechanical ventilation may prevent aspiration which is likely the main cause of pneumonia in these patients.

Registry
clinicaltrials.gov
Start Date
April 2005
End Date
February 2009
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University of Versailles
Responsible Party
Principal Investigator
Principal Investigator

Djillali Annane

Professor in medicine

University of Versailles

Eligibility Criteria

Inclusion Criteria

  • Guillain Barré Syndrome
  • Age of 18 years old or more
  • Inability to lift head
  • Time from onset of motor deficit less than 7 days
  • Written informed consent

Exclusion Criteria

  • Glasgow coma score of less than 8
  • Unstable hemodynamic status
  • Current pneumonia
  • Pregnancy

Outcomes

Primary Outcomes

Rate of hospital acquired pneumonia from randomization to study day 90

Time Frame: Day 90

Secondary Outcomes

  • Hospital length of stay(Day 90)
  • Tolerance(Day 90)
  • Intensive care unit lenght of stay(Day 90)
  • Time on a ventilator(Day 90)

Study Sites (1)

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