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Early Mechanical Ventilation for Guillain Barré Syndrome

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00167622
Enrollment
50
Registered
2005-09-14
Start date
2005-04-30
Completion date
2009-02-28
Last updated
2016-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Respiratory Failure, Guillain Barré Syndrome

Keywords

Guillain Barré, Mechanical ventilation, invasive, Mechanical ventilation, non invasive, Pneumonia

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.

Interventions

PROCEDUREmechanical ventilation

Non invasive mechanical ventilation at least 6 hours per day - if difficult swallowing, tracheal intubation and invasive mechanical ventilation

PROCEDUREphysiotherapy and oxygen if needed

oxygen will be delivered via facial mask whenever needed and physiotherapy

Sponsors

Assistance Publique - Hôpitaux de Paris
CollaboratorOTHER
University of Versailles
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Rate of hospital acquired pneumonia from randomization to study day 90Day 90

Secondary

MeasureTime frame
Time on a ventilatorDay 90
Intensive care unit lenght of stayDay 90
Hospital length of stayDay 90
ToleranceDay 90

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026