Trial document





This trial has been registered retrospectively.
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  DRKS00004436

Trial Description

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Title

Optimized ventilation strategy in ARDS patients using transpulmonary pressures and volumetric capnography: an observational study

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Trial Acronym

TPP Study

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Utilising transpulmonary pressure settings instead of conventional ventilator parameter settings in lung failure patients may in conjunction with volumetric capnometry parameters lead to a less invasive setting of ventilator parametres and thus reduce ventilator induced lung injury. In this observational study, we aim to evaluate the effects of these novel approaches to ventilator settings in acute lung failure.
Transpulmonary pressure is defined as the difference between airway pressure in the lung and the pressure in the tissues surrounding the lung. Volumetric capnography is a method allowing measurement of carbon dioxide concentration during breathing and the amount of carbon dioxide. Using both methods we aim to enhance patient respirator settings. Therefore, a comparison between conventional respirator settings and the new methods using volumetric capnography and transpulmonary pressure measurements is being conducted.
Both volumetric capnography and transpulmonary pressure measurements are already being used in clinical routine, however, clinical data regarding their efficiency in improving respiratory function are still lacking. Every patient with acute lung failure that is recruited into the study will be ventilated both by conventional settings and then by the novel method utilising volumetric capnography and transpulmonary pressure for a period of approximately 3-4 hours. Following the study period, all patients then return to conventional respirator therapy. Depending on a randomisation based on chance, the study either starts with the conventional respirator settings or with the transpulmonary pressure/ volumetric capnography settings. Then, during the course of the study the patient is switched again to the other method of ventilator settings.

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Brief Summary in Scientific Language

Setting a positivie transpulmonary pressure, particularly at endexspiratory hold maneuvers may be crucial to avoid alveolar cycling, a well recognised cause of ventilator-induced lung injury (VILI). Using ARDSnet criteria to guide ventilator settings in ARDS may not always be sufficient to avoid VILI due to large interindividual fluctuations in pleural, extrapulmonary pressure in the ARDS cohort. Therefore, using esophageal pressure probes to estimate transpulmonary pressures at endexspiratory hold may be a valid method to avoid alveolar cycling. In conjunction with volumetric capnometry, dead space measurements are possible, providing for further methods to evaluate the best ventilator settings for each individual patient.
In this observational study, we will perform an incremental / decremental PEEP trial with PEEP ranges from 5 to 15 cm H2O. During the trial we will measure volumetric capnometry data and transpulmonary pressures, as well as multiple other ventilatory parameters to check for the best PEEP setting for each patient.

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Organizational Data

  •   DRKS00004436
  •   2012/10/11
  •   [---]*
  •   yes
  •   Approved
  •   21/02/2012, Ethik-Kommission der Medizinischen Fakultät der Georg-August-Universität Göttingen
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Secondary IDs

  •   U1111-1135-3159 
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Health Condition or Problem studied

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

  •   Patients with ARDS:
    3-4h study period using measurements of transpulmonary pressures and volumetric capnography during mechanical ventilation. Setting airway pressure based on published ARDSnet criteria for ventilating ARDS patients.
  •   Patients with ARDS:
    3-4h study period using measurements of transpulmonary pressures and volumetric capnography during mechanical ventilation. Setting airway pressure based on transpulmonary pressures and volumetric capnography data according to the published criteria by Talmor for ventilation based on transpulmonary pressure measurements.
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Characteristics

  •   Non-interventional
  •   Other
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Treatment
  •   Crossover
  •   N/A
  •   N/A
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Primary Outcome

Oxygenation: measuring paO2 every 20 min after each new PEEP level, measured by blood gas analysis

Dead space ventilation: measured in ml, every 20 mins using volumetric capnography

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Secondary Outcome

Airway pressures
every 20 min, measured by ventilator

transpulmonary pressures
every 20 min, measured by esophageal pressure monitor

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2012/05/08
  •   30
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   120   Years
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Additional Inclusion Criteria

ARDS
P/F ratio less than 300
mechanically ventilated

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Exclusion Criteria

lack of consent, severe preexisting lung disease, ECMO therapy , PECLA therapy

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Addresses

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    • ZARI , UMG Göttingen
    • Mr.  Dr. med.  Onnen  Mörer 
    • Robert-Koch-Str. 40
    • 37099  Göttingen
    • Germany
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    • ZARI , UMG Göttingen
    • Mr.  Dr. med.  Onnen  Mörer 
    • Robert-Koch-Str. 40
    • 37099  Göttingen
    • Germany
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    • ZARI , UMG Göttingen
    • Mr.  Dr. med.  Onnen  Mörer 
    • Robert-Koch-Str. 40
    • 37099  Göttingen
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsmedizin Göttingen Zentrum Anaesthesiologie, Rettungs- und Intensivmedizin
    • Robert-Koch-Straße 40
    • 37099  Göttingen
    • Germany
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Status

  •   Recruiting ongoing
  •   [---]*
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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.