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Early Mechanical Ventilation for Guillain Barré Syndrome

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00167622
First Posted: September 14, 2005
Last Update Posted: July 20, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Assistance Publique - Hôpitaux de Paris
Information provided by (Responsible Party):
Djillali Annane, University of Versailles
  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
Intervention Model: Parallel Assignment
Masking: Single (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 Djillali Annane, University of Versailles:

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

Secondary Outcome Measures:
  • Time on a ventilator [ Time Frame: Day 90 ]
  • Intensive care unit lenght of stay [ Time Frame: Day 90 ]
  • Hospital length of stay [ Time Frame: Day 90 ]
  • Tolerance [ Time Frame: Day 90 ]

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

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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, Professor in medicine, University of Versailles
ClinicalTrials.gov Identifier: NCT00167622     History of Changes
Other Study ID Numbers: P050103
PS050103
First Submitted: September 10, 2005
First Posted: September 14, 2005
Last Update Posted: July 20, 2016
Last Verified: July 2016

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

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