Trial document




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  DRKS00016974

Trial Description

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Title

Quantification of recruitable alveolar collapse and overdistension during laparoscopic GYNEcological surgery and mechanical VENTilation

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Trial Acronym

GYNEVENT-Trial

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URL of the Trial

[---]*

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Brief Summary in Lay Language

"Minimally-invasive" surgery with laparoscopy may lead to deterioration of regional lung function that complicates mechanical ventilation due to insufflation of carbon dioxide (CO2) in the abdominal cavity and the "heads down" position during surgery. However, mechanical ventilation is necessary for general anesthesia during laparoscopy. Individualized optimal adjustment of positive end-expiratory pressure (PEEP) during anesthesia could help to overcome these difficulties and improve regional lung function.
In this study, we will use electrical impedance tomography (EIT) to visualize regional lung function and identify the PEEP level that is necessary to prevent lung collapse and improve lung function during laparoscopic gynecological surgery.

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Brief Summary in Scientific Language

Background:
Laparoscopic surgery in Trendelenburg position may lead to deterioration of lung function and regional collapse of alveoli. Optimal levels of positive end-expiratory pressure may help to prevent alveolar collapse and improve pulmonary function during laparoscopic surgery in Trendelenburg position.

Aim of study:
Using electrical impedance tomography (EIT), we want to identify the PEEP level necessary for preventing alveolar collapse during laparoscopic surgery.

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Organizational Data

  •   DRKS00016974
  •   2019/03/14
  •   [---]*
  •   yes
  •   Approved
  •   D426/19, Ethikkommission der Christian-Albrechts-Universität zu Kiel
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Secondary IDs

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Health Condition or Problem studied

  •   Mechanical ventilation during laparoscopic surgery
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Interventions/Observational Groups

  •   Decremental PEEP-trial in steps of 2 mbar, starting with 20 mbar, down to 4 mbar
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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

Lowest PEEP level with no relevant alveolar collapse in 30° Trendelenburg position with capnoperitoneum.

"Relevant" defined as more than 3% of relative collapse when analyzing the whole PEEP trial.

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Secondary Outcome

1. Percentage of relative lung overdistension during mechanical ventilation at the PEEP level corresponding to the primary end point
2. PEEP level with same percentage of relative overdistension and relative collapse
3. Lowest PEEP level with no relevant alveolar collapse after induction of anesthesia in horizontal position without capnoperitoneum (for definition of "relevant" see primary outcome)
4. PEEP level with highest global respiratory system compliance
5. Correlation between intraabdominal pressure and PEEP level necessary for primary end point
6. Blood pressure, heart rate and oxygen saturation at abovementioned PEEP levels in comparison to baseline (baseline = after induction of anesthesia, PEEP 5 mbar)
7. Influence of duration of capnoperitoneum on ventilation distribution immediately before and after extubation and on oxygen saturation in recovery room (30 minutes after extubation, room air).

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2019/03/15
  •   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

Patients (m/f/d) with planned laparoscopic surgery in Trendelenburg position, written informed consent.

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Exclusion Criteria

Body mass index > 35 kg/m2; metal chest implants, open thoracic lesions, pregnancy, participation in other interventional studies, chronic lung diseases

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Addresses

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    • Klinik für Anästhesiologie und Operative Intensivmedizin, Universtitätsklinikum Schleswig-Holstein, Campus Kiel
    • Mr.  Dr.  Tobias  Becher 
    • Arnold-Heller-Str. 3, Haus 12
    • 24105  Kiel
    • Germany
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    • Klinik für Anästhesiologie und Operative Intensivmedizin, Universitätsklinikum Schleswig-Holstein, Campus Kiel
    • Mr.  Dr.  Tobias  Becher 
    • Arnold-Heller-Str.3, Haus 12
    • 24105  Kiel
    • Germany
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    • Klinik für Anästhesiologie und Operative Intensivmedizin
    • Mr.  Dr.  Henning  Ohnesorge 
    • Arnold-Heller-Str.3, Haus 12
    • 24105  Kiel
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Schleswig-Holstein, Campus Kiel, Klinik für Anästhesiologie und Operative Intensivmedizin
    • Arnold-Heller-Str. 3 Haus 12
    • 24105  Kiel
    • 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.