Trial document




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  DRKS00004263

Trial Description

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Title

Nonlinear mechanics of the respiratory system in controlled ventilated patients of the anesthesiological Intensive Care Unit

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

During their treatment in the anesthesiological ICU some patients are mechanically ventilated. We want to measure the pressure in the respiratory system for calculating the nonlinear mechanical properties of the respiratory system. In this context "PEEP" is the minimal pressure being set during mechanical ventilation. "Nonlinear" in this context means that the mechanical properies of the respiratory system may change in dependence of pressure.
During mechanical ventilation respiratory pressures are recorded for 30 min. Furthermore diagnostic parameters, e.g. heartrate and oxygenation are protocollized.
10 min after measurement onset the PEEP will be increased by 5 mbar and 10 min later PEEP will be reset to the primarily set level. After subsequent 10 min the measurement will be terminated.
Target of the study is to investigate the situation of the ventilated patient from a mechanical point of view.

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Brief Summary in Scientific Language

We have developed analytical methods for analysing non-linear respiratory system mechanics of a mechanically ventilated patient in the ICU [1,2].
Wit the ARDSnet study [3] it could be demonstrated that mortality of ARDS patients was reduced when they were ventilated with a tidal volume of 6ml/kg compared to 12 ml/kg. A low tidal volume is therefore considered as lung-protective. In this study we want to investigate in which range of the non-linear dynamic compliance, i.e. the dynamic pressure-volume curve of the respiratory system controlled mechanically ventilated patients of our anesthesiologial ICU are ventilated and how far the suggestiong for setting mechanical ventilation are considered. Furthermore the respiratory system mechanics of the patient shall be compared to those when the PEEP is increased by 5mbar.



[1] Guttmann et al. Determination of volume-dependent respiratory system mechan-ics 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 2010 Feb;31(2):261-72
[3] ARDSNetwork. Ventilation with lower tidal volumes as compared with traditional tidal volumes for acute lung injury and the acute respiratory distress syndrome. N Eng J Med (2000); 342 (18); 1301-1308
[4] Mols et al. Volume-dependent compliance in ARDS: proposal of a new diagnostic concept. Intensive Care Med (1999) 25: 1084-1091

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Organizational Data

  •   DRKS00004263
  •   2012/07/19
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  •   yes
  •   Approved
  •   68/12, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

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Health Condition or Problem studied

  •   ARDS
  •   J80 -  Adult respiratory distress syndrome
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Interventions/Observational Groups

  •   At the mechanically ventilated patient pressure and flow rate data are collected from the ventilator. After 10 min of data recording, PEEP will be increased by 5 mbar for 10 min and subsequently set back to the original value. After data recording for further 10 min the measurement will be stopped.
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Basic research/physiological study
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

The temporal courses of airway pressure and flow rate are recorded from the ventilator. These data are processed to the intratidal profile of respiratory system compliance in an offline analysis.

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Secondary Outcome

Expiratory CO2 and blood pressures as determined by the available monitoring system are protocollized. Data analysis is performed offline after the meaurements.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2012/08/01
  •   30
  •   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

controlled mechanically ventilated patients with ARDS

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Exclusion Criteria

age < 18 years, pregnancy, missing informed consent, terminal phase of disease

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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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    • Anästhesiologisches Universitätsklinikum Freiburg
    • 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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