Trial document




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  DRKS00008545

Trial Description

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Title

Effects of intraoperative recruitment manoeuvres on the respiratory sytem mechanics of lung-healthy children during elective surgery with general anesthesia

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

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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

  •   DRKS00008545
  •   2015/06/08
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  •   yes
  •   Approved
  •   03/15, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

  •   U1111-1170-9530 
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Health Condition or Problem studied

  •   PATIENTS WITH DIFFERENT SURGICAL PROCEDURES
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Interventions/Observational Groups

  •   Application from initially PEEP 3 mbar and than 7 mbar, before each application recruitment maneuver
  •   Application from initially PEEP 7 mbar and than 3 mbar, before each application recruitment maneuver
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   investigator/therapist
  •   Active control (effective treament of control group)
  •   Treatment
  •   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
  •   2015/06/12
  •   60
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   no minimum age
  •   12   Years
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Additional Inclusion Criteria

Age between 1-12 years, written parental consent

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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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    • Klinik für Anästhesiologie und IntensivmedizinUniversitätsklinikum Freiburg
    • 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
  •   2016/12/20
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Trial Publications, Results and other Documents

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