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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
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Tracking Information
First Submitted Date November 30, 2009
First Posted Date December 2, 2009
Last Update Posted Date September 16, 2014
Study Start Date March 2008
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 30, 2009)
Correlation between respiratory failure and bulbar dysfunction during ICU stay [ Time Frame: 24 MONTHS ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01024088 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: November 30, 2009)
Number of aspiration pneumonia [ Time Frame: 24 MONTHS ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Prospective Study on Swallowing/Breathing Interactions in Severe Guillain Barre Syndrome.
Official Title Prospective Study on Swallowing/Breathing Interactions in Severe Guillain Barre Syndrome.
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.
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 Observational
Study Design Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population patient admitted in ICU with GBS and respiratory risk
Condition
  • Tetraplegia
  • Respiratory Failure
Intervention Not Provided
Study Groups/Cohorts
  • GBS PATIENT
  • CONTROL
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: November 30, 2009)
60
Original Estimated Enrollment Same as current
Actual Study Completion Date July 2012
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT01024088
Other Study ID Numbers P061016 -CRC 06040
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Assistance Publique - Hôpitaux de Paris
Study Sponsor Assistance Publique - Hôpitaux de Paris
Collaborators Not Provided
Investigators
Principal Investigator: David Orlikowski, PH Assistance Publique - Hôpitaux de Paris
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date February 2011