Clinical trial NCT00167622: Early Mechanical Ventilation for Guillain Barré Syndrome
Official title: Efficacy and Safety of Preventive Mechanical Ventilation in Adults With Guillain Barré Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Guillain Barré Syndrome
Acute Respiratory Failure
Keywords: Guillain Barré
Mechanical ventilation, invasive
Mechanical ventilation, non invasive
Pneumonia
Lead sponsor: University of Versailles
Sponsor class: OTHER
Collaborators: name: Assistance Publique - Hôpitaux de Paris
First posted: 2005-09-14
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of hospital acquired pneumonia from randomization to study day 90
timeFrame: Day 90
Secondary outcomes:
measure: Time on a ventilator
timeFrame: Day 90
measure: Intensive care unit lenght of stay
timeFrame: Day 90
measure: Hospital length of stay
timeFrame: Day 90
measure: Tolerance
timeFrame: Day 90
Other outcomes:
Locations:
city: Garches
country: France
facility: Raymond Poincaré Hospital
Study officials:
affiliation: Raymond Poincaré Hospital, AP-HP
name: Djillali annane, MD, PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.