Early Mechanical Ventilation for Guillain Barré Syndrome

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

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

Study Overview

• Status: Completed
• Conditions: Acute Respiratory Failure; Guillain Barré Syndrome
• Intervention / Treatment: Procedure: physiotherapy and oxygen if needed; Procedure: mechanical ventilation

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 2

Contacts and Locations

Study Locations

• France
  • Garches, France, 92380
    • Raymond Poincaré Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1; Physiotherapy, oxygen as needed	Procedure: physiotherapy and oxygen if needed; oxygen will be delivered via facial mask whenever needed and physiotherapy
Experimental: 2; Mechanical ventilation	Procedure: mechanical ventilation; Non invasive mechanical ventilation at least 6 hours per day - if difficult swallowing, tracheal intubation and invasive mechanical ventilation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rate of hospital acquired pneumonia from randomization to study day 90	Day 90

Secondary Outcome Measures

Outcome Measure	Time Frame
Hospital length of stay	Day 90
Time on a ventilator	Day 90
Intensive care unit lenght of stay	Day 90
Tolerance	Day 90

Collaborators and Investigators

• Sponsor: University of Versailles
• Collaborators: Assistance Publique - Hôpitaux de Paris

Publications and helpful links

General Publications

• Sharshar T, Chevret S, Bourdain F, Raphael JC; French Cooperative Group on Plasma Exchange in Guillain-Barre Syndrome. Early predictors of mechanical ventilation in Guillain-Barre syndrome. Crit Care Med. 2003 Jan;31(1):278-83. doi: 10.1097/00003246-200301000-00044.
• Chevrolet JC, Deleamont P. Repeated vital capacity measurements as predictive parameters for mechanical ventilation need and weaning success in the Guillain-Barre syndrome. Am Rev Respir Dis. 1991 Oct;144(4):814-8. doi: 10.1164/ajrccm/144.4.814.
• Melone MA, Heming N, Meng P, Mompoint D, Aboab J, Clair B, Salomon J, Sharshar T, Orlikowski D, Chevret S, Annane D. Early mechanical ventilation in patients with Guillain-Barre syndrome at high risk of respiratory failure: a randomized trial. Ann Intensive Care. 2020 Sep 30;10(1):128. doi: 10.1186/s13613-020-00742-z.

Study record dates

Study Major Dates

• Study Start: April 1, 2005
• Primary Completion (Actual): January 1, 2009
• Study Completion (Actual): February 1, 2009

Study Registration Dates

• First Submitted: September 10, 2005
• First Submitted That Met QC Criteria: September 10, 2005
• First Posted (Estimate): September 14, 2005

Study Record Updates

• Last Update Posted (Estimate): July 20, 2016
• Last Update Submitted That Met QC Criteria: July 19, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: Pneumonia; Guillain Barré; Mechanical ventilation, invasive; Mechanical ventilation, non invasive
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Respiratory Tract Diseases; Immune System Diseases; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Respiration Disorders; Disease; Neuromuscular Diseases; Peripheral Nervous System Diseases; Polyradiculoneuropathy; Polyneuropathies; Syndrome; Respiratory Insufficiency; Guillain-Barre Syndrome
• Other Study ID Numbers: P050103; PS050103