Trial document




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  DRKS00006033

Trial Description

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Title

Dependency of respiratory mechanics and ventilation from PEEP during mechanical ventilation for elective surgery by children

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Trial Acronym

Kinder-EIT

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URL of the Trial

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Brief Summary in Lay Language

During surgery the patients be mechanically ventilated. In this time we measure the pressure in the respiratory system and calculated the non-lineare compliance from the respiratory systems. During the measurement we change the PEEP values in two steps. The aim of our study is, how to change the respiratory mechanics in different PEEP step by children

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Brief Summary in Scientific Language


The studies in lung healthy children during mechnical ventilation has been largely neglected.
We want to investigate the area in which the non-linear compliance [1, at different stages of PEEP during mechanical ventilation,changed. The gliding slice method is used [2,3]. In addition, to be investigated by the electrical impedance tomography how the gas distribution is affected in the lungs.


[1] Guttmann et al. Determination of volume-dependent respiratory system mechanics in mechanically ventilated patients using the new SLICE method Technology und Health Care, 2 (1994) 175-191
[2] Schumann et al. Estimating intratidal nonlinearity of respiratory system mechan-ics: a model study using the enhanced gliding-SLICE Method Physiol Meas 2009 Dec; 30:1341-1356.
[3] Schumann et al. Analysis of dynamic intratidal compliance in a lung collapse model. Anesthesiology 2011 May;114(5):1111-1117.

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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

  •   DRKS00006033
  •   2014/04/22
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  •   yes
  •   Approved
  •   35/14, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

  •   U1111-1154-9145 
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Health Condition or Problem studied

  •   patient under elective surgery
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Interventions/Observational Groups

  •   Application from initially PEEP 2 mbar and than 5 mbar
  •   Application from initially PEEP 5 mbar and than 2 mbar
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject
  •   Active control (effective treament of control group)
  •   Prevention
  •   Crossover
  •   N/A
  •   N/A
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Primary Outcome

Perioperative non-lineare compliance (ml/mbar) fom the end of the induction of anaesthesia till the end of the surgery

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Secondary Outcome

Perioperative regional ventilation measure with the electrical impedance tomography lung fom the end of the induction of anaesthesia till the end of the surgery

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2015/03/01
  •   40
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   1   Years
  •   12   Years
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Additional Inclusion Criteria

Age between 1-12 years

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Exclusion Criteria

lung desease, pacemaker, implanted heart defibrillator, heart vitien

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Addresses

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    • Universitätsklinikum Freiburg
    • Hugstetter Strasse 49
    • 79095  Freiburg
    • Germany
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    • Universitätsklinikum FreiburgKlinik für Anästhesiologie und Intensivmedizin
    • Mr.  Dr.  Steffen  Wirth 
    • Hugstetter Strasse 55
    • 79100  Freiburg
    • Germany
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    • Klinik für Anästhesiologie und IntensivmedizinUniversitätsklinikum Freiburg
    • Mr.  Dr.  Steffen  Wirth 
    • Hugstetter Strasse 55
    • 79100  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Klinik für Anästhesiologie und IntensivmedizinUniversitätsklinikum Freiburg
    • Mr.  Dr.  Steffen  Wirth 
    • Hugstetter Strasse 55
    • 79100  Freiburg
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2015/10/08
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Trial Publications, Results and other Documents

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