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

Respiratory Failure Clinical Trial

— DGVSB  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01024088
• Other study ID #: P061016 -CRC 06040
• Status: Completed
• Phase: N/A
• First received: November 30, 2009
• Last updated: September 15, 2014
• Start date: March 2008
• Est. completion date: July 2012

Study information

• Verified date: February 2011
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Guillain-Barre Syndrome
• Respiratory Failure
• Respiratory Insufficiency
• Tetraplegia

Locations

Country	Name	City	State
France	hôpital Raymond Poincaré	Garches

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation between respiratory failure and bulbar dysfunction during ICU stay		24 MONTHS	No
Secondary	Number of aspiration pneumonia		24 MONTHS	No