Early Mechanical Ventilation for Guillain Barré Syndrome

Acute Respiratory Failure Clinical Trial

Official title:

Efficacy and Safety of Preventive Mechanical Ventilation in Adults With Guillain Barré Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00167622
• Other study ID #: P050103
• Secondary ID: PS050103
• Status: Completed
• Phase: Phase 2
• First received: September 10, 2005
• Last updated: July 19, 2016
• Start date: April 2005
• Est. completion date: February 2009

Study information

• Verified date: July 2016
• Source: University of Versailles
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether early mechanical ventilation can prevent hospital acquired pneumonia in adults with Guillain Barré Syndrome.

Description:

Hospital acquired pneumonia is a common and severe complication of Guillain Barré Syndrome. Several factors have been recognized as predictors of respiratory failure in adults with Guillain Barré Syndrome. They include a time from disease onset and patient admission of less seven days, inability to lift head, impaired swallowing and a forced vital capacity of less than 60% of predictive value. We reasonned that early mechanical ventilation may prevent aspiration which is likely the main cause of pneumonia in these patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: February 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Guillain Barré Syndrome

• Age of 18 years old or more

• Inability to lift head

• Time from onset of motor deficit less than 7 days

• Written informed consent

Exclusion Criteria:

• Glasgow coma score of less than 8

• Unstable hemodynamic status

• Current pneumonia

• Pregnancy

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Respiratory Failure
• Guillain Barré Syndrome
• Guillain-Barre Syndrome
• Respiratory Distress Syndrome, Adult
• Respiratory Insufficiency
• Syndrome

Intervention

Procedure:
• mechanical ventilation
Non invasive mechanical ventilation at least 6 hours per day - if difficult swallowing, tracheal intubation and invasive mechanical ventilation
• physiotherapy and oxygen if needed
oxygen will be delivered via facial mask whenever needed and physiotherapy

Locations

Country	Name	City	State
France	Raymond Poincaré Hospital	Garches

Sponsors (2)

Lead Sponsor	Collaborator
University of Versailles	Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (2)

Chevrolet JC, Deléamont P. Repeated vital capacity measurements as predictive parameters for mechanical ventilation need and weaning success in the Guillain-Barré syndrome. Am Rev Respir Dis. 1991 Oct;144(4):814-8. — View Citation

Sharshar T, Chevret S, Bourdain F, Raphaël JC; French Cooperative Group on Plasma Exchange in Guillain-Barré Syndrome. Early predictors of mechanical ventilation in Guillain-Barré syndrome. Crit Care Med. 2003 Jan;31(1):278-83. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of hospital acquired pneumonia from randomization to study day 90		Day 90	Yes
Secondary	Time on a ventilator		Day 90	No
Secondary	Intensive care unit lenght of stay		Day 90	No
Secondary	Hospital length of stay		Day 90	No
Secondary	Tolerance		Day 90	Yes