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Prospective Study on Swallowing/Breathing Interactions in Severe Guillain Barre Syndrome. (DGVSB)

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. Identifier: NCT01024088
Recruitment Status : Completed
First Posted : December 2, 2009
Last Update Posted : September 16, 2014
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:
To estimate, in a longitudinal and not invasive way, in patients with SGB at respiratory risk, the function of respiratory muscles and that of the upper airways muscles by investigating the force of the tongue, the gulp, and the breath during the sleep to be able to detect bulbar impairment and establish correlations enter the various parameters to estimate better the interactions between the dysfunction of the respiratory muscles and that upper airways muscles and so determine the risk acute respiratory failure.

Condition or disease
Tetraplegia Respiratory Failure

Detailed Description:

Context: the syndrome of Guillain Barré ( SGB) is the first causes of extensive paralysis of medical origin in industrial nations. A third of these patients going to require mechanical invasive ventilation during their stay in ICU. This population of ventilated presents the strongest risk of infectious respiratory patient complications and death. The respiratory impairment is a progressive weakness of inspiratory and expiratory muscles. The monitoring of the respiratory muscular infringement is usually made by the repeated measure of vital capacity and the maximal respiratory pressures. The occurrence of bulbar impairment is an aggravating element entailing dysfunction of the upper airways muscles detected often late in front of aspiration. Besides the arisen of sleep apneas was never sought in this context. This dysfunction of the upper airways muscles could be more detected prematurely by objectivizes measures of them performances.

Method: longitudinal observational and in a one center study. The respiratory impairment will be estimated by the measure of the vital capacity, maximal respiratory pressures and of the debit of cough. The existence of a bulbar infringement will be sought by the measure of the force of the tongue, an objective measure of gulp performances and a polysomnographic recording.

Criterion of selection: patient admitted in ICU with GBS and respiratory risk. Number of patients, centre: 40 patients admitted in the intensive care unit of the hospital RAYMOND POINCARE and 20 controls.

Duration of the study: 24 months Perspectives: better anticipate acute respiratory failure and the indication of an invasive ventilation.

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Study Type : Observational
Actual Enrollment : 60 participants
Time Perspective: Prospective
Official Title: Prospective Study on Swallowing/Breathing Interactions in Severe Guillain Barre Syndrome.
Study Start Date : March 2008
Actual Primary Completion Date : July 2012
Actual Study Completion Date : July 2012


Primary Outcome Measures :
  1. Correlation between respiratory failure and bulbar dysfunction during ICU stay [ Time Frame: 24 MONTHS ]

Secondary Outcome Measures :
  1. Number of aspiration pneumonia [ Time Frame: 24 MONTHS ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
patient admitted in ICU with GBS and respiratory risk

Inclusion Criteria:

  • Guillain Barré Syndrome
  • Presenting a risk of mechanical ventilation(breakdown): presence of 2 among the following 5 criteria

    • Deficit evolving for less than 7 days
    • Impossibility to stand up
    • Impossibility to raise the head
    • ineffective Cough
    • Vital capacity< 60 %

Exclusion Criteria:

  • MAJOR confusions of gulp (spontaneous) at admittance
  • Respiratory distress syndrome and intubation at admission buccal dental lesions
  • Not membership to a regime of Social Security (beneficiary or legal successor)
  • Patient under guardianship or custody

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 identifier (NCT number): NCT01024088

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hôpital Raymond Poincaré
Garches, France, 92380
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
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Principal Investigator: David Orlikowski, PH Assistance Publique - Hôpitaux de Paris
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Responsible Party: Assistance Publique - Hôpitaux de Paris Identifier: NCT01024088    
Other Study ID Numbers: P061016 -CRC 06040
First Posted: December 2, 2009    Key Record Dates
Last Update Posted: September 16, 2014
Last Verified: February 2011
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Guillain Barré syndrome
Swallowing disorders
Respiratory failure
Additional relevant MeSH terms:
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Respiratory Insufficiency
Guillain-Barre Syndrome
Respiration Disorders
Respiratory Tract Diseases
Neurologic Manifestations
Nervous System Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Autoimmune Diseases
Immune System Diseases