Trial document



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  DRKS00014925

Trial Description

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Title

Influence of flow-controlled ventilation (FCV) on regional ventilation in obese patients.

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Trial Acronym

FCV and obesity

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URL of the Trial

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Brief Summary in Lay Language

Obesity leads to many changes of the human organism. These changes also influence the respiratory system and thus the breathing and ventilation of obese patients. Animal research showed, that a new form of ventilation (flow-controlled ventilation, FCV) could influence the ventilation and gas exchange positively. The primary aim of this study is to examine the effect of FCV on the regional ventilation in obese patients. Therefore, 20 patients will be ventilated via conventional volume-controlled ventilation and flow-controlled ventilation. During the course of mechanical ventilation, measurement of regional ventilation via electrical impedance tomography will be used to determine changes in regional ventilation.

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Brief Summary in Scientific Language

Obesity leads to negative effects on pulmonary function, ventilation mechanics, resistance, compliance, lung volumes, gas exchange, muscular work and the efficiency of ventilation [1]. Due to these pathophysiologic changes, obese patients have an increased risk of postoperative pulmonary complications, such as pneumonia or pulmonary embolism [2, 3]. Findings from experimental studies suggest, that a flow-controlled ventilation via FCV, compared to volume controlled ventilation, can homogenize ventilation [4]. In the way described above, obese patients might benefit from this homogenization of ventilation.
The primary aim of this study is to examine the effect of a FCV on the regional ventilation in obese patients and to test the hypothesis of an improved homogenization caused by this form of ventilation. Therefore, 20 obese patients, scheduled for bariatric surgery, get ventilated with volume-controlled ventilation and flow-controlled ventilation alternately. During the course of mechanical ventilation, the regional ventilation is measured by electrical impedance tomography. The ventilation system EVA uses a thin endotracheal tube with an outer diameter of 4.4 mm (usual endotracheal tubes have an outer diameter between 9.5 mm for women and 10.8 mm for men). The endotracheal tube of the FCV ventilation system is applied over a conventional tube, so that it can be removed at any time. After the measurement is finished, the FCV tube gets removed and further (intraoperative) ventilation can be performed conventionally.


[1]: Salome CM, King GG, Berend N. Physiology of obesity and effects on lung function. J Appl Physiol. 2010;108(1):206–211.
[2]: Pelosi P, Croci M, Ravagnan I, et al. The effects of body mass on lung volumes, respiratory mechanics, and gas exchange during general anesthesia. Anesth Analg 1998;87:654-60.
[3]: Latimer, RG, Dickman, M, Day, WC, Gunn, ML, Schmidt, CD. Ventilatory patterns and pulmonary complications after upper abdominal surgery determined by preoperative and postoperative computerized spirometry and blood gas analysis. Am J Surg. 1971;122:622–632.
[4]: Schmidt et al.: Improved lung recruitment and oxygenation during mandatory ventilation with a new expiratory ventilation assistance device: A controlled interventional trial in healthy pigs. DOI: 10.1097/EJA.0000000000000819
[5]: Schumann et al.: Determination of respiratory system mechanics during inspiration and expiration by FLow-controlled EXpiration (FLEX): a pilot study in anesthetized pigs. Minerva anestesiologica 2014;80:19–28.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00014925
  •   2018/07/12
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  •   yes
  •   Approved
  •   179/18 , Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

  •   U1111-1217-0075 
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Health Condition or Problem studied

  •   E66.0 -  Obesity due to excess calories
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Interventions/Observational Groups

  •   There is one group of patients. This group will be split (randomly) into two different intervention groups. Within these two groups, the different ventilation settings will be applied in a cross-over manner as follows.

    1. volume-controlled baseline ventilation (BL)
    2. EVA ventilation (FCV)
    3. volume-controlled ventilation (VCV)
  •   1. volume-controlled baseline ventilation (BL)
    2. volume-controlled ventilation (VCV)
    3. EVA ventilation (FCV)
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Other
  •   Other
  •   Crossover
  •   N/A
  •   N/A
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Primary Outcome

Regional ventilation (end-expiratory lung volume), measured via electrical impedance tomography

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Secondary Outcome

Volumes, pressures and flows of ventilation (plateau pressure, mean tracheal airway pressure, respiratory system compliance, haemodynamic variables: heart rate and mean arterial pressure), ins- and expiratory concentration of oxygen and carbon dioxide, mean lung volume (EIT).

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2018/07/30
  •   20
  •   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

≥ 18 years of age, elective surgery, ASA (American Society of Anesthesiologists) status 1-3, obesity with BMI ≥ 30 kg/m², written consent of the patient.

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Exclusion Criteria

COPD (stadium COPD ≥ Gold III, clinical presentation, other known lung diseases, pacemaker, implantable cardioverter-defibrillator or other active electrical implants, heart defect, urgent surgery.

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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 Universitätsklinikum Freiburg
    • Mr.  Prof. Dr. rer. nat.  Stefan  Schumann 
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
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    • Klinik für Anästhesiologie und Intensivmedizin Universitätsklinikum Freiburg
    • Mr.  Prof. Dr. rer. nat.  Stefan  Schumann 
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Europäische Kommission Förderprogramm Horizont 2020
    • 1047  Brüssel
    • Belgium
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Status

  •   Recruiting complete, follow-up complete
  •   2018/10/23
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Trial Publications, Results and other Documents

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