Trial document





This trial has been registered retrospectively.
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  DRKS00006073

Trial Description

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Title

Near infrared spectroscopy monitoring (NIRS) during selective cerebral perfusion and deep hypothermic cardiocirculatory arrest

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Trial Acronym

[---]*

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Main purpose of this study is to investigate the predictive value of near infrared spectroscopy (NIRS ) as a diagnostic method in patients undergoing cardiac surgery in deep hypothermic circulatory arrest and selective cerebral perfusion for prediction of perioperative stroke in radiological imaging. Background of the study is that neurological complications, particularly strokes, often occur after cardiac surgery at the aortic arch operated in circulatory arrest and selective cerebral perfusion and represent a major cause of postoperative morbidity and mortality. In patients undergoing cardiac surgery at the aorta in deep hypothermic circulatory arrest and selective cerebral perfusion, regional oxygen saturation of the brain tissue is monitored non-invasively by means of near infrared spectroscopy (NIRS). The primary objective of this study is to examine the near infrared spectroscopy (NIRS) as a method for monitoring cerebral oxygenation in patients during aortic arch surgery with selective cerebral perfusion and deep hypothermic circulatory arrest on their predictive value with regard to perioperative stroke in radiological imaging.

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Brief Summary in Scientific Language

Neurological complications, particularly strokes, during aortic arch surgery occur often and are major causes of postoperative morbidity and mortality. To protect the brain, selective cerebral perfusion is a well-established and commonly performed procedure in aortic arch surgery with hypothermic circulatory.
Near-infrared spectroscopy provides a non-invasive method for monitoring of the regional cerebral tissue oxygen saturation.
The primary objective of this study is to assess in patients undergoing aortic arch surgery with selective cerebral perfusion and deep hypothermic circulatory arrest whether the near-infrared spectroscopy as a method for cerebral monitoring has any predictive value for perioperative stroke.

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Organizational Data

  •   DRKS00006073
  •   2014/05/06
  •   [---]*
  •   yes
  •   Approved
  •   13-5667-BO, Ethik-Kommission der Medizinischen Fakultät der Universität Duisburg-Essen
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   I63 -  Cerebral infarction
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Interventions/Observational Groups

  •   Near infrared spectroscopy (NIRS) (patients undergoing deep hypothermic cardiocirculatory arrest and selective cerebral perfusion)
  •   No near infrared spectroscopy (NIRS) (patients undergoing deep hypothermic cardiocirculatory arrest and selective cerebral perfusion)
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Characteristics

  •   Interventional
  •   [---]*
  •   Non-randomized controlled trial
  •   Blinded
  •   patient/subject
  •   Other
  •   Diagnostic
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Testing of the predictive value of near-infrared spectroscopy (oxygen saturation of brain tissue) for the prediction of stroke in radiological imaging

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Secondary Outcome

Incidence of stroke in radiological imaging in relation to near infrared spectroscopy (regional cerebral tissue oxygen saturation)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2013/12/05
  •   140
  •   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

Operations during deep hypothermic circulatory arrest and selective cerebral perfusion

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Exclusion Criteria

no operations during deep hypothermic circulatory arrest and selective cerebral perfusion

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Addresses

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    • Klinik für Anästhesiologie und Intensivmedizin Universitätsklinikum Essen Universität Duisburg-Essen
    • Mr.  Prof. Dr.  Jürgen  Peters 
    • Hufelandstrasse 55
    • 45122  Essen
    • Germany
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    • Klinik für Anästhesiologie und Intensivmedizin Universitätsklinikum Essen Universität Duisburg-Essen
    • Ms.  PD Dr.  Eva  Kottenberg 
    • Hufelandstrasse 55
    • 45122  Essen
    • Germany
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    • Klinik für Anästhesiologie und Intensivmedizin Universitätsklinikum Essen Universität Duisburg-Essen
    • Ms.  PD Dr.  Eva  Kottenberg 
    • Hufelandstrasse 55
    • 45122  Essen
    • Germany
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Sources of Monetary or Material Support

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    • Klinik für Anästhesiologie und Intensivmedizin Universitätsklinikum Essen Universität Duisburg-Essen
    • Mr.  Prof. Dr.  Jürgen  Peters 
    • Hufelandstrasse 55
    • 45122  Essen
    • Germany
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Status

  •   Recruiting complete, follow-up continuing
  •   [---]*
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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.