Prospective Study on Swallowing/Breathing Interactions in Severe Guillain Barre Syndrome. (DGVSB)
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|ClinicalTrials.gov Identifier: NCT01024088|
Recruitment Status : Completed
First Posted : December 2, 2009
Last Update Posted : September 16, 2014
|Condition or disease|
|Tetraplegia Respiratory Failure|
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.
|Study Type :||Observational|
|Actual Enrollment :||60 participants|
|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|
U.S. FDA Resources
- Correlation between respiratory failure and bulbar dysfunction during ICU stay [ Time Frame: 24 MONTHS ]
- Number of aspiration pneumonia [ Time Frame: 24 MONTHS ]
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): NCT01024088
|hôpital Raymond Poincaré|
|Garches, France, 92380|
|Principal Investigator:||David Orlikowski, PH||Assistance Publique - Hôpitaux de Paris|