- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01024088
Prospective Study on Swallowing/Breathing Interactions in Severe Guillain Barre Syndrome. (DGVSB)
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Garches, France, 92380
- Hôpital Raymond Poincaré
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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GBS PATIENT
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CONTROL
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Correlation between respiratory failure and bulbar dysfunction during ICU stay
Time Frame: 24 MONTHS
|
24 MONTHS
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of aspiration pneumonia
Time Frame: 24 MONTHS
|
24 MONTHS
|
Collaborators and Investigators
Investigators
- Principal Investigator: David Orlikowski, PH, Assistance Publique - Hôpitaux de Paris
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Respiratory Tract Diseases
- Immune System Diseases
- Autoimmune Diseases of the Nervous System
- Demyelinating Diseases
- Autoimmune Diseases
- Respiration Disorders
- Neurologic Manifestations
- Neuromuscular Diseases
- Peripheral Nervous System Diseases
- Paralysis
- Polyradiculoneuropathy
- Polyneuropathies
- Respiratory Insufficiency
- Quadriplegia
- Guillain-Barre Syndrome
Other Study ID Numbers
- P061016 -CRC 06040
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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