Trial document




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  DRKS00009768

Trial Description

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Title

Application of the positive endexpiratory pressure (PEEP) based on respiratory system mechanics compared with the empirical setting during laparoscopic procedure and with obese patients having elective surgery under general anesthesia

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Trial Acronym

Gui-Lap-Adip

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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 obesity and patients with minimally invasive surgery of the abdomen. There are different ways to avoid the formation of atelectasis. Aim of the study is to improve the situation of artificially ventilated patients. Therefore we want to examine the influence of an elevated positive endexspiratory pressure (PEEP) on the patients lung-mechanics. Our main indicator for the condition of the patients lung will be the so called "compliance". It gives us information about the flexibility of the lung and constantly changes throughout a breath. There is an approximate value the compliance should have, indicating the most lung-protective setting of the PEEP. Our group has developed a method to measure the compliance during a breath that can be used during a surgery, giving advice on how to set the PEEP to the most lung-protective magnitude.
We will be using this graphical user interface (GUI) on 60 patients, of which 30 will get active modulation of their PEEP-setting. They will be compared to the other 30 patients who will be ventilated with the commonly used PEEP of 5mbar. We are assuming that a higher PEEP-setting will have a positive influence on compliance and ventilation. Throughout the artificial ventilation we will also measure the effectiveness of the ventilation using another method developed by our group. For possible recruitment patients have to be adult and lung-healthy, group A with obesity (BMI>30kg/m²), group B under laparoscopic procedure. Only routine and planned surgery is allowed.

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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] and ist supposed to decrease the formation of atelectasis. Two groups of patients have an enhanced risk of formation of atelectasis caused by increased intraabdominal pressure: First patients havin laparoscopic surgery und second patients with an obesity with a body-mass-index (BMI) >30kg/m2. Both groups suffer intraoperatively from compression of lung tissue - caused by the pressure of the pneumoperitoneum or the increased body mass, respectively - resulting in decreased compliance of lung and thorax according to a restrictive ventilation disorder. Therefore we want to figure out how much the PEEP has to be increased to achieve a maximum in lung-protection. Thus, in one group of patients PEEP will be set according to the graphical user interface (GUI) our group has developed[2]. It is using the gliding-SLICE-method, also developed by our group[3,4]. Another group of patients will get the commonly used PEEP setting of 5mbar and will serve as a comparison. For both groups, we will also be using electrical impedance tomography (EIT) to measure the quality of 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] Bühler et al. Monitoring of intratidal lung mechanics: a Graphical User Interface for a model-based decision support system for PEEP- titration in mechanical ventilation J Clin Monit Comput 2014 28:613–623
[3] 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
[4] 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

  •   DRKS00009768
  •   2015/12/08
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  •   yes
  •   Approved
  •   389/15, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

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Health Condition or Problem studied

  •   mechanical ventilation
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Interventions/Observational Groups

  •   30 healthy volunteers will be given the commonly used positive endexspiratory pressure (PEEP) of 5mbar for the complete duration of the surgery.
  •   Positive endexspiratory pressure (PEEP) of 5mbar will be given to 30 healthy volunteers in the beginning of artificial ventilation. During surgery, PEEP will be set according to the graphical user interface (GUI). Maximum PEEP to be applied is 12mbar.
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Characteristics

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

Perioperative non-linear intratidal compliance, continously measured [ml/mbar] from the end of induction until the end of the surgery

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Secondary Outcome

Continuously measured perioperative regional ventilation (using EIT (electrical impedance tomography) - pixel) as well as Oxygenation (SaO2, PaO2), drawn from standard-monitoring, from the end of induction until the end of the surgery

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2016/04/11
  •   60
  •   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

adults of at least 18 years of age, informed written consent, elective surgery, artificial ventilation, laparoscopic surgery or Obesity (BMI>30kg/m2) respectively

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Exclusion Criteria

known pulmonary disease, cardiac pacemaker, automated implantable cardioverter-defibrillator or other active implants, heart defects

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Addresses

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    • Uniklinikum Freiburg
    • Hugstetter Str. 55
    • 79100  Freiburg
    • Germany
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    • Klinik für Anästhesiologie und IntensivmedizinUniklinik Freiburg
    • Dr.  Steffen  Wirth 
    • Hugstetter Str. 55
    • 79100  Freiburg
    • Germany
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    • Klinik für Anästhesiologie und IntensivmedizinUniklinik Freiburg
    • Mr.  Dr.  Steffen  Wirth 
    • Hugstetter Str.55
    • 79100  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Klinik für Anästhesiologie und IntensivmedizinUniklinik Freiburg
    • Mr.  Dr.  Steffen  Wirth 
    • Hugstetter Str.55
    • 79100  Freiburg
    • Germany
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    •   +49761270240101
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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