Trial document




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  DRKS00004247

Trial Description

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Title

Impact of different positive end-expiratory pressure (PEEP) with low tidal volumes during one-ventilation on lung mechanics, gas exchange, and hemodynamics

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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, air is pumped into the lungs with a mechanical ventilator. When surgery is performed on the lung, only the other lung can be ventilated (one-lung ventilation). This study addresses the question, how to improve the ventilator setting during one-lung ventilation

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Brief Summary in Scientific Language

Low tidal volume ventilation is usually applied to patients with adult respiratory distress syndrome (ARDS). Recent studies suggest that low tidal volume ventilation may also be effective during surgery in anesthetized patients without pulmonary diseases. However, large randomized studies are missing and low tidal volume ventilation may have side effects in pulmonary healthy patients as it may induce atelectasis. This study investigates whether lung recruitment before one-lung ventilation and different PEEP levels affect the oxygenation and onset of atelectasis during low tidal volume ventilation.

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Organizational Data

  •   DRKS00004247
  •   2012/07/24
  •   [---]*
  •   yes
  •   Approved
  •   3185-07/11, Ethikkommission der Friedrich-Schiller-Universität Jena an der Medizinischen Fakultät
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Secondary IDs

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Health Condition or Problem studied

  •   Onel-lung ventilation
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Interventions/Observational Groups

  •   Lung recruitment before one-lung ventilation / PEEP 5
  •   Lung recruitment before one-lung ventilation / PEEP 8
  •   No lung recruitment before one-lung ventilation / PEEP 5
  •   No lung recruitment before one-lung ventilation / PEEP 8
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Factorial
  •   N/A
  •   N/A
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Primary Outcome

Oxygenation after 30 min one-lung ventilation measured by arterial pO2 in the blood gas analysis

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Secondary Outcome

Dynamic compliance during one-lung ventilation calculated from the parameters of mechanical ventilation,
Ventilation during one-lung ventilation measured by arterial pCO2 in the blood gas analysis,
Frequency of clinically significant hypoxemia (necessity to apply CPAP or two-lung ventilation)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2012/08/15
  •   276
  •   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

Thoracic Surgery
Onelung ventilation

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Exclusion Criteria

Lack of informed consent
Incapability to give informed consent
Severe impairment of pulmonary function (<75%)
Previous partial lung resection

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Addresses

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    • Zentralklinik Bad Berka Klinik für Anästhesie und Intensivemdizin
    • Mr.  Prof. Dr.  Wahedulla  Karzai 
    • Robert-Koch-Allee 9
    • 99437  Bad Berka
    • Germany
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    • Jena University Hospital Center for Sepsis Control & Care
    • Mr.  Dr. med.  Frank  Bloos 
    • Erlanger Allee 101
    • 07747  Jena
    • Germany
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    • Zentralklinik Bad Berka Klinik für Anästhesie und Intensivemdizin
    • Mr.  Prof. Dr.  Wahedulla  Karzai 
    • Robert-Koch-Allee 9
    • 99437  Bad Berka
    • Germany
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    • Zentralklinik Bad Berka Klinik für Anästhesie und Intensivemdizin
    • Mr.  Prof. Dr.  Wahedulla  Karzai 
    • Robert-Koch-Allee 9
    • 99437  Bad Berka
    • Germany
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Sources of Monetary or Material Support

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    • Zentralklinik Bad Berka GmbH
    • Robert-Koch-Allee 9
    • 99437  Bad Berka
    • 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.