Early Mechanical Ventilation for Guillain Barré Syndrome

U

University of Versailles

Status and phase

Completed
Phase 2

Conditions

Acute Respiratory Failure
Guillain Barré Syndrome

Treatments

Procedure: physiotherapy and oxygen if needed
Procedure: mechanical ventilation

Study type

Interventional

Funder types

Other

Identifiers

NCT00167622
P050103
PS050103

Details and patient eligibility

About

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

Full 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.

Enrollment

50 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

50 participants in 2 patient groups

1
Active Comparator group
Description:
Physiotherapy, oxygen as needed
Treatment:
Procedure: physiotherapy and oxygen if needed
2
Experimental group
Description:
Mechanical ventilation
Treatment:
Procedure: mechanical ventilation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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