Trial document



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  DRKS00004901

Trial Description

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Title

Measurements of depth of anesthesia based on the base signal as compared to the
bispectralindex

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

The depth of anesthesia monitoring based prior to the introduction the EEG on indirect autonomic parameters such heart rate, blood pressure, sweating and tears secretion. By using the EEG was the anesthetic monitoring possible. The aim of this monitoring procedure is to avoid a to deep anesthesia and on the other hand to prevent a to low anesthesia with the risk awareness. The previous methods concentrate themselves mainly of the derivation of brain activity. The aim of this study based on vegetative parameters for example heart frequency variation and the respiratory signal (capnography) with mathematical calculations for the purposes of a neurofuzzy system to obtain an indicator of depth of anesthesia. We do not require any further methods of monitoring. We only need the data levied anyway, prepare the data mathematically and compare with the measurement of depth of anesthesia bispectralindex (BIS)

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Brief Summary in Scientific Language

The goal of adequate anesthesia must it be, to avoid a too deep anesthesia without the risk of awareness. The depth of anesthesia monitoring based prior to the introduction the EEG on indirect vegetative parameters such heart rate, blood pressure, sweating and tears secretion. With the EEG the electical activity of the brain can be visualized, an adequate assessment about the depth of anesthesia is possible only to a limited. There are several monitoring systems of different methods of analysis algorithms. The aim of this study is with vegetative parameters and mathematic calculations in terms of a fuzzy sytems, to obtain an indicator of depth of anethesia.It will be data they already exist, heart rate variation (EKG), respiratory signal (capnography, oxygen saturation) mathemaical prepare. The mathematically derived from this index is compared with the established methods the bispsectral index (BIS). Is it possible to measure the depth of anesthesia without additional measuring method we can use this system in the future as a standard monitoring and to help to improve the anesthetic management

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00004901
  •   2013/04/25
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  •   yes
  •   Approved
  •   123/13, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

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Health Condition or Problem studied

  •   The depth of anesthesia monitoringby patients with different diseases
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Interventions/Observational Groups

  •   Simultaneous measurement of bispsectralindex and vegetative parameters like heart rate variation (EKG), respiratory signal (capnography, oxygen saturation)
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Characteristics

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

Dimensionsless index for the measurement of the depth of anesthesia

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Secondary Outcome

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2013/04/25
  •   30
  •   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

written consent, patient controlled mechanical ventilation

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Exclusion Criteria

age < 18 years, pregnancy, critical illness

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Addresses

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    • Universitätsklinikum Freiburg
    • Hugstetter Strasse 49
    • 79095  Freiburg
    • Germany
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    • Anästhesiologische Klinik Universitätsklinikum Freiburg
    • Mr.  Dr.  Steffen Olievr  Wirth 
    • Hugstetter Strasse 55
    • 79100  Freiburg
    • Germany
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    • Anästhesiologische Klinik Universitätsklinikum Freiburg
    • Mr.  Dr.  Steffen Oliver  Wirth 
    • Hugstetter Strasse 55
    • 79100  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Freiburg
    • Hugstetter Strasse 49
    • 79095  Freiburg
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2013/12/11
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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.