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

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

Study Description

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.

Study Design

• 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

Groups and Cohorts

Group/Cohort
GBS PATIENT
CONTROL

Outcome Measures

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 ]

Eligibility Criteria

• 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

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

Locations

France

hôpital Raymond Poincaré

Garches, France, 92380

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators

• Principal Investigator: David Orlikowski, PH; Assistance Publique - Hôpitaux de Paris

More Information

• Responsible Party: Assistance Publique - Hôpitaux de Paris
• ClinicalTrials.gov Identifier: NCT01024088 History of Changes
• Other Study ID Numbers: P061016 -CRC 06040
• First Posted: December 2, 2009
• 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:

Respiratory Insufficiency; Quadriplegia; Guillain-Barre Syndrome; Respiration Disorders; Respiratory Tract Diseases; Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Polyradiculoneuropathy; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Polyneuropathies; Autoimmune Diseases; Immune System Diseases