Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00004236

Trial Description

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Title

Respiratory Muscle Assessment in Acute Guillain-Barré-Syndrome

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Trial Acronym

[---]*

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URL of the Trial

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Brief Summary in Lay Language

In this study we want to examine respiratory muscle affection in patients with acute Guillain-Barré-Syndrome. Patients may exhibit severe respiratory muscle affection with the need of mechanical ventilation in the acute onset of this disease. Therefore, tests of respiratory muscle function that are easy to apply and interpret are clearly needed.
This study wants to examine various tests of respiratory muscle function within the first week of disease onset in patients with acute Guillain-Barré-Syndrome.

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Brief Summary in Scientific Language

So far no complete assessment of respiratory muscle function in acute Guillain-Barré-Syndrom has been performed. Patients with acute Guillain-Barrè-Syndrome are at great risk of developing a respiratory type II failure with need of mechanical ventilation.
The current practice of measuring vital capacity only represents an indirect way of assessing respiratory muscle function. Therefore, tests of respiratory muscle function that are acurate, easy to apply and directed at the respiratory muscles are clearly needed.
This study aims at assessing respiratory muscle function with all respiratory muscle evaluation techniques currently available in acute Guillain-Barrè Syndrom. The time course of respiratory muscle affection within the first week of disease onset will be measured and linked to the clinical presentation of the subject.

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Organizational Data

  •   DRKS00004236
  •   2012/07/09
  •   [---]*
  •   yes
  •   Approved
  •   226/07, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

  •   U1111-1132-4302 
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Health Condition or Problem studied

  •   G61.0 -  Guillain-Barré syndrome
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Interventions/Observational Groups

  •   Respiratory muscle evaluation using various assessment-techniquies in patients with acute Guillain Barré Syndrome
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Characteristics

  •   Non-interventional
  •   Other
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Diagnostic
  •   Single (group)
  •   N/A
  •   [---]*
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Primary Outcome

Objectively assessed respiratory muscle affection of the diaphragm using magnetic phrenic nerve stimulation in patients with Guillain-Barrè Syndrome within the first week of disease onset.

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Secondary Outcome

What is the time course of respiratory muscle affection in acute Guillain-Barré Syndrome?
Are there better prognostic markers than vital capacity measurements in acute Guillain-Barrè Syndrome to assess respiratory muscle affection?
Is vital capacity assessment linked to indices of respiratory muscle function?

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2007/10/01
  •   20
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Acute Guillain-Barré-Syndrome

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Exclusion Criteria

pre-existing respiratory muscle disorders
pre-existing neuromuscular disease other Guillain-Barré-Syndrome
severe restrictive chest disease
severe respiratory infectious disease
obstructive lung function impairment (FEV1/FVC<70%)
systemic steroid therapy (daily prednisolone equivalent >10mg)
electronically implanted devices
metal implants in the head/neck region
coagulation disorder (Quick<30%)
pregnancy
severe obstructive sleep apnea

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Uniklinik Freiburg Abt. Pneumologie
    • Mr.  PD Dr.  Hans-Joachim  Kabitz 
    • Killianstr. 5
    • 79106  Freiburg
    • Germany
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    • Uniklinik Freiburg Abt. Pneumologie
    • Mr.  PD Dr.  Hans-Joachim  Kabitz 
    • Killianstr. 5
    • 79106  Freiburg
    • Germany
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    • Uniklinik Freiburg Abt. Pneumologie
    • Mr.  PD Dr.  Hans-Joachim  Kabitz 
    • Killianstr. 5
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Forschungsgemeinschaft
    • Kennedyallee 40
    • 53175  Bonn
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2008/12/01
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.