Trial document




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  DRKS00009332

Trial Description

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Title

Respiratory mechanics and ventilation using controlled exspiration (FLEX) during elective laparoscopic surgery under general anesthesia

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Trial Acronym

FLEX Lap

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URL of the Trial

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Brief Summary in Lay Language

For surgery there is often the need of mechanical ventilation. We want to determine and evaluate some characteristics of the respiratory tract in this period. During mechanical ventilation the pulmonary alveoles often collapse in defined areas (atelectasis). This formation of atelectasis is even increased by elevated pressure in the abdomen. Exactly this happens in patients with minimally invasive surgery of the abdomen. There are different ways to avoid the formation of atelectasis. In our study we want to compare two methods to improve mechanical ventilation in the future.

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Brief Summary in Scientific Language

The analysis of respiratory mechanics during mechanical ventilation is more and more of scientific interest. The quality of ventilation is assessed via gas exchange, in particular via the peripheral oxygen saturation and the end-tidal CO2. There is evidence that an increased positive end-exspiratory pressure (PEEP) may prevent lung injury caused by mechanical ventilation [1, 2]. Flow-controlled exspiration may create a similar effect without increased PEEP [3]. Both methods are supposed to decrease the formation of atelectasis. Patients for laparoscopic surgery have an enhanced risk of formation of atelectasis caused by increased intraabdominal pressure. Caused by the pressure of the pneumoperitoneum the patients suffer intraoperatively from compression of lung tissue resulting in a decreased compliance of lung and thorax according to a restrictive ventilation disorder. In this study we want to compare the flow-controlled expiration with the application of PEEP. Data analysis will be performed with the gliding-SLICE method, a development of our study group [4,5]. We hope to gain insights for the best possible mechanical ventilation.

[1] Futier et al. A Trial of Intraoperative Low-Tidal-Volume Ventilation in Abdominal Surgery N Engl J Med 2013;369:428-37
[2] Wirth et al. Intraoperative positive end-expiratory pressure evaluation using the intratidal compliancevolume profile. Br J Anaesth. 2015 Mar;114(3):483-90
[3] Schumannn et al. Determination of respiratory system mechanics during inspiration and expiration by FLow-controlled EXpiration (FLEX) Minerva Anestesiol 2014 Jan;80(1):19-28
[4] Schumann et al. Estimating intratidal nonlinearity of respiratory system mechanics: a model study using the enhanced gliding-SLICE Method Physiol Meas 2009 Dec; 30:1341-1356
[5] Schumann et al. Analysis of dynamic intratidal compliance in a lung collapse model. Anesthesiology 2011 May;114(5):1111-1117

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Organizational Data

  •   DRKS00009332
  •   2015/09/07
  •   [---]*
  •   yes
  •   Approved
  •   355/15, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   perioperative mechanical ventilation
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Interventions/Observational Groups

  •   Application of positive end-exspiratory pressure (PEEP) of 7mbar for 5 minutes of calibration followed by 20 minutes for data collection. Then Cross-over with PEEP of 7mbar in addition to controlled exspiration (FLEX) for 5 minutes of calibration followed by 20 minutes of data collection.
  •   Application of positive end-exspiratory pressure (PEEP) of 7mbar in addition to controlled exspiration (FLEX) for 5 minutes of calibration followed by 20 minutes for data collection. Then Cross-over with PEEP of 7mbar for 5 minutes of calibration followed by 20 minutes of data collection.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject
  •   Active control (effective treament of control group)
  •   Prevention
  •   Crossover
  •   N/A
  •   N/A
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Primary Outcome

non-linear intratidal Compliance calculated with the generated respiratory data using the gliding-SLICE method. Respiratory data are collected during the entire experiment, calculation of compliance is performed after terminating the experiment.
(see also: Schumann et al. Estimating intratidal nonlinearity of respiratory system mechanics: a model study using the enhanced gliding-SLICE Method Physiol Meas 2009 Dec; 30:1341-1356;
Schumann et al. Analysis of dynamic intratidal compliance in a lung collapse model. Anesthesiology 2011 May;114(5):1111-1117)

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Secondary Outcome

Oxygenation (SaO2, PaO2) determined by arterial blood gas samples;
point in time: after calibration (t0),after 10 minutes (t1) and after 20 minutes (t2)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2016/11/02
  •   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

elective surgery, controlled ventilation, laparoscopic surgery

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Exclusion Criteria

known lung diseases, Pacemaker, implantable cardioverter/defibrillator, intracardial malformation

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Addresses

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    • Universitätsklinikum Freiburg
    • Hugstetter Strasse 49
    • 79095  Freiburg
    • Germany
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    • Klinik für Anästhesiologie und Intensivmedizin
    • Mr.  Dr. med.  Steffen  Wirth 
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
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    • Klinik für Anästhesiologie und Intensivmedizin
    • Mr.  Dr. med.  Steffen  Wirth 
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Klinik für Anästhesiologie und Intensivmedizin
    • Mr.  Dr. med.  Steffen  Wirth 
    • 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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* This entry means the parameter is not applicable or has not been set.