Trial document




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  DRKS00003973

Trial Description

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Title

Analysis of pressure and flow characteristics in children using either machine-guided, pressure controlled mask ventilation or manual mask ventilation

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Trial Acronym

DFP

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URL of the Trial

[---]*

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Brief Summary in Lay Language

This study will be conducted in the department of Anesthesiology at the University Medical Center Freiburg. The main purpose is the evaluation of airway pressure during manual and machinal mask ventilation. Patients undergoing general anesthesia will receive either manual or machinal mask ventilation and flow and pressure parameters will be analyzed. Potential candidates for this study include children until the age of 12 years of age.
The hypothesis to be checked is that airway pressure should be more constant during machinal ventilation rather than in manual ventilation. It is the aim of this study to find out the best treatment option to lower airway pressure.

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Brief Summary in Scientific Language

Manual mask ventilation is a routine during anesthesia induction in children until the airway is definitely secured. After pre oxygenation of the patient, anesthesia is induced using analgetics and hypnotics and - if necessary - muscular relaxation.
As soon as the individual spontanous breathing suspends, mask ventilation will be done until anesthesia depths is reached to intubate the patients´ lungs. Until then, the patient is manually ventilated by the anesthesist using a face mask.
Generally, during this period there is always the risk of air-insufflation in the stomach with the risk of regurgitation and possible aspiration.
As a consequence, pneumonia oder ARDS may result, increasing perioperative morbidity and mortality. Thus, any insufflation of the stomach should be avoided. During manual mask ventilation, the APL pressure release valve secures, that no air gets through the esophagus (limiting the pressure to 20 mbar). Airwaypressure, flow and frequency of ventilation are intended by the anesthesist.
Utilizing pressure controlled machine ventilation, these parameters can be chosen and will be applicated in a constantly safe manner. There is data for adults, showing a reduction of stomach insufflation with air due to this constant form of ventilation. There is an order to perform this maneuver in children, but there is a lack of data (Wissenschaftlicher Arbeitskreis Kinderanästhesie, Anästh. Intensivmed. 48 (2007): S88-93).
Moreover, using mechanically assisted ventilation, the anesthesist now is able to use both hands in case of a difficult airway scenario.
It is the aim of this study to evaluate pressure and flow characteristics to reduce airway pressure in constant ventilation.

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Organizational Data

  •   DRKS00003973
  •   2012/05/16
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  •   yes
  •   Approved
  •   140/12, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

  •   U1111-1130-7818 
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Health Condition or Problem studied

  •   ventilation during induction of anesthesia
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Interventions/Observational Groups

  •   just manual mask ventilation
  •   mask ventilation via anesthesia machine
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, assessor
  •   Active control
  •   Prevention
  •   Crossover
  •   N/A
  •   N/A
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Primary Outcome

Maxima of flow and pressure: Comparison between manual and machine ventilation

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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
  •   2012/07/03
  •   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

every Patient with age below 12 years requiring general anesthesia

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Exclusion Criteria

GERD, non-conpliance

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Addresses

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    • Anästhesiologische Universitätsklinik
    • Mr.  PD Dr.  Ulrich  Göbel 
    • Hugstetter Strasse 55
    • 79106  Freiburg
    • Germany
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    • Anästhesiologische Universitätsklinik
    • Mr.  PD Dr.  Ulrich  Göbel 
    • Hugstetter Strasse 55
    • 79106  Freiburg
    • Germany
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    • Anästhesiologische Universitätsklinik
    • Mr.  PD Dr.  Ulrich  Göbel 
    • Hugstetter Strasse 55
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Anästhesiologische Universitätsklinik
    • Mr.  PD Dr.  Ulrich  Göbel 
    • Hugstetter Strasse 55
    • 79106  Freiburg
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2013/08/01
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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.