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

NCT01024088 | Completed

• 1 other identifier: P061016 -CRC 06040
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Tetraplegia; Respiratory Failure

Keywords

Guillain Barré syndrome; Swallowing disorders; Respiratory failure

Outcome Measures

Primary Outcomes (1)

• Correlation between respiratory failure and bulbar dysfunction during ICU stay

  24 MONTHS

Secondary Outcomes (1)

• Number of aspiration pneumonia

  24 MONTHS

Study Arms (2)

GBS PATIENT

CONTROL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patient admitted in ICU with GBS and respiratory risk

You may qualify if:

• 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 %

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

hôpital Raymond Poincaré

Garches, 92380, France

Location

MeSH Terms

Conditions

Quadriplegia; Respiratory Insufficiency; Guillain-Barre Syndrome; Deglutition Disorders

Condition Hierarchy (Ancestors)

Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Respiratory Tract Diseases; Polyradiculoneuropathy; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Autoimmune Diseases; Immune System Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Study Officials

• David Orlikowski, PH

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2009
• First Posted: December 2, 2009
• Study Start: March 1, 2008
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: September 16, 2014

Record last verified: 2011-02

Locations

FR (1)