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Trial record 6 of 20 for:    Guillain-Barré Syndrome
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Early Mechanical Ventilation for Guillain Barré Syndrome

This study has been completed.
Sponsor:
Collaborator:
Assistance Publique - Hôpitaux de Paris
Information provided by:
University of Versailles
ClinicalTrials.gov Identifier:
NCT00167622
First received: September 10, 2005
Last updated: February 17, 2009
Last verified: February 2009
History of Changes
  Purpose

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:

U.S. FDA Resources

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00167622

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

Publications:

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
Pneumonia

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

ClinicalTrials.gov processed this record on June 17, 2013