Early Mechanical Ventilation for Guillain Barré Syndrome

This study has been completed.
Assistance Publique - Hôpitaux de Paris
Information provided by:
University of Versailles
ClinicalTrials.gov Identifier:
First received: September 10, 2005
Last updated: February 17, 2009
Last verified: February 2009
The purpose of this study is to determine whether early mechanical ventilation can prevent hospital acquired pneumonia in adults with Guillain Barré Syndrome.

Condition Intervention Phase
Guillain Barré Syndrome
Acute Respiratory Failure
Procedure: mechanical ventilation
Procedure: physiotherapy and oxygen if needed
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Preventive Mechanical Ventilation in Adults With Guillain Barré Syndrome

Resource links provided by NLM:

Further study details as provided by University of Versailles:

Primary Outcome Measures:
  • Rate of hospital acquired pneumonia from randomization to study day 90 [ Time Frame: Day 90 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Time on a ventilator [ Time Frame: Day 90 ] [ Designated as safety issue: No ]
  • Intensive care unit lenght of stay [ Time Frame: Day 90 ] [ Designated as safety issue: No ]
  • Hospital length of stay [ Time Frame: Day 90 ] [ Designated as safety issue: No ]
  • Tolerance [ Time Frame: Day 90 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: April 2005
Study Completion Date: February 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Physiotherapy, oxygen as needed
Procedure: physiotherapy and oxygen if needed
oxygen will be delivered via facial mask whenever needed and physiotherapy
Experimental: 2
Mechanical ventilation
Procedure: mechanical ventilation
Non invasive mechanical ventilation at least 6 hours per day - if difficult swallowing, tracheal intubation and invasive mechanical ventilation

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.

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00167622

Raymond Poincaré Hospital
Garches, France, 92380
Sponsors and Collaborators
University of Versailles
Assistance Publique - Hôpitaux de Paris
Study Chair: Djillali annane, MD, PhD Raymond Poincaré Hospital, AP-HP
  More Information

Responsible Party: Djillali Annane, Assistance Publique Hôpitaux de Paris - University of Versailles SQY
ClinicalTrials.gov Identifier: NCT00167622     History of Changes
Other Study ID Numbers: P050103  PS050103 
Study First Received: September 10, 2005
Last Updated: February 17, 2009
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University of Versailles:
Guillain Barré
Mechanical ventilation, invasive
Mechanical ventilation, non invasive

Additional relevant MeSH terms:
Guillain-Barre Syndrome
Respiratory Distress Syndrome, Adult
Respiratory Insufficiency
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Diseases
Immune System Diseases
Lung Diseases
Nervous System Diseases
Neuromuscular Diseases
Pathologic Processes
Peripheral Nervous System Diseases
Respiration Disorders
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 24, 2016