Trial document




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  DRKS00004963

Trial Description

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Title

Estimation of intrinsic PEEP by measurement of endexpiratory flow rate

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

During mechanical ventilation, the positive end-expiratory pressure inside the lungs (intrinsic PEEP) can be much higher compared to the one that is measured at the airway opening (PEEP) and displayed by the ventilator.
We have developed a method for calculating the pressure inside the trachea from knowledge of flow rate and the size of the endotracheal tube [1-3].
This method is not implemented in clinical routine but it could improve the clinical monitoring. In the current study we aim at calculating the intrinsiv PEEP. Therefore we compare the calculated intrinsic PEEP to the PEEP measured directly via a pressure measurement catheter and to that measured via a manoeuver integrated in the ventilator.
Therefore we will measure airway pressure and flow rate in ventilated patients for 15 minutes. Via an additional sid port the pressure inside the trachea will be measured directly and every 5 minutes the manoeuver for determination of intrinsic PEEP will be performed. The study will be performed in pediatric patiens since setting of ventilation parameters is difficult in those patients and therefore intrinsic PEEP plays a special role.

[1] Guttmann J, Kessler V, Mols G, Hentschel R, Haberthür C, Geiger K. Continuous calculation of intratracheal pressure in the presence of pediatric endotracheal tubes. Crit Care Med. 2000 Apr;28(4):1018-26. [2] Haberthür C, Lichtwarck-Aschoff M, Guttmann J. Continuous monitoring of tracheal pressure including spot-check of endotracheal tube resistance. Technol Health Care. 2003;11(6):413-24. [3] Lichtwarck-Aschoff M, Helmer A, Kawati R, Lattuada M, Sjöstrand UH, Zügel N, Guttmann J, Hedenstierna G.Good short-term agreement between measured and calculated tracheal pressure. Br J Anaesth. 2003 Aug;91(2):239-48.

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Brief Summary in Scientific Language

In patients whos lungs are intubated and mechanically ventilated we want to test how reliable the intrinsic PEEP canl be estimated by calculation [1,2,3] in comparison to direct measurement and to a measurement-maneuver.

[1] Guttmann J, Kessler V, Mols G, Hentschel R, Haberthür C, Geiger K. Continuous calculation of intratracheal pressure in the presence of pediatric endotracheal tubes. Crit Care Med. 2000 Apr;28(4):1018-26. [2] Haberthür C, Lichtwarck-Aschoff M, Guttmann J. Continuous monitoring of tracheal pressure including spot-check of endotracheal tube resistance. Technol Health Care. 2003;11(6):413-24. [3] Lichtwarck-Aschoff M, Helmer A, Kawati R, Lattuada M, Sjöstrand UH, Zügel N, Guttmann J, Hedenstierna G.Good short-term agreement between measured and calculated tracheal pressure. Br J Anaesth. 2003 Aug;91(2):239-48.

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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

  •   DRKS00004963
  •   2013/05/07
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  •   yes
  •   Approved
  •   32/13, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

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Health Condition or Problem studied

  •   Mechanically ventilated patients
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Interventions/Observational Groups

  •   In mechanically ventilated patients of the pediatric intensive care unit airway pressure, gas flow and tracheal pressure are measured.
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Characteristics

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

End-expiratory Intratracheal pressure during a 15 minute period, repeatedly measured directly, estimated via measurement manoeuvre and calculated.

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Secondary Outcome

No secondary outcome

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Planned
  •   2013/05/13
  •   12
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

Mechanically ventilated patients of the pediatric intensive care unit, formal parental consent

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Exclusion Criteria

severe lung injury, teminal state of disease, missing formal consent

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Addresses

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    • Anästhesiologische Universitätsklinik Freiburg
    • Mr.  Dr.  Stefan  Schumann 
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
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    • Anästhesiologische Universitätsklinik Freiburg
    • Mr.  Dr.  Stefan  Schumann 
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
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    • Anästhesiologische Universitätsklinik Freiburg
    • Mr.  Dr.  Stefan  Schumann 
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Anästhesiologische Universitätsklinik Freiburg
    • Mr.  Dr.  Stefan  Schumann 
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
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Status

  •   Recruiting planned
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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.