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Completed

NCT Number: NCT00167622

Early Mechanical Ventilation for 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.

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Key information

Conditions

Guillain Barré Syndrome Acute Respiratory Failure Autoimmune Diseases Autoimmune Diseases of the Nervous System Chronic Disease Demyelinating Diseases Disease Attributes Guillain-Barre Syndrome Immune System Diseases Infections Lung Diseases Nervous System Diseases Neuromuscular Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Pneumonia Polyneuropathies Polyradiculoneuropathy Post-Infectious Disorders Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Raymond Poincaré Hospital

Garches, 92380, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

mechanical ventilation

Procedure

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

physiotherapy and oxygen if needed

Procedure

oxygen will be delivered via facial mask whenever needed and physiotherapy

Primary outcomes

  1. Rate of hospital acquired pneumonia from randomization to study day 90

    Time frame: Day 90

Secondary outcomes

  1. Time on a ventilator

    Time frame: Day 90

  2. Intensive care unit lenght of stay

    Time frame: Day 90

  3. Hospital length of stay

    Time frame: Day 90

  4. Tolerance

    Time frame: Day 90

Sponsors and collaborators

Lead sponsor

University of Versailles

Other

Collaborators

  • Assistance Publique - Hôpitaux de Paris

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2009
Study completion
2009
First posted
Sep 14, 2005
Registry last updated
Jul 20, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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