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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01024088
First received: November 30, 2009
Last updated: February 23, 2011
Last verified: February 2011
History of Changes
  Purpose

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
Tetraplegia
Respiratory Failure

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Prospective Study on Swallowing/Breathing Interactions in Severe Guillain Barre Syndrome.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Correlation between respiratory failure and bulbar dysfunction during ICU stay [ Time Frame: 24 MONTHS ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of aspiration pneumonia [ Time Frame: 24 MONTHS ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: March 2008
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
GBS PATIENT
CONTROL

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

patient admitted in ICU with GBS and respiratory risk

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01024088

Locations
France
hôpital Raymond Poincaré Recruiting
Garches, France, 92380
Contact: David Orlikowski, MD     147107776 ext +33     david.orlikowski@rpc.aphp.fr    
Principal Investigator: David orlikowski, MD            
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: David Orlikowski, PH Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Cecile Jourdain, Department Clinical Research of developpement
ClinicalTrials.gov Identifier: NCT01024088     History of Changes
Other Study ID Numbers: P061016 -CRC 06040
Study First Received: November 30, 2009
Last Updated: February 23, 2011
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Guillain Barré syndrome
Swallowing disorders
Respiratory failure

Additional relevant MeSH terms:
Quadriplegia
Guillain-Barre Syndrome
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
Paralysis
Neurologic Manifestations
Signs and Symptoms
Respiration Disorders
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 23, 2013