Trial document




drksid header

  DRKS00014925

Trial Description

start of 1:1-Block title

Title

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

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

FCV and obesity

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

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.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

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.

end of 1:1-Block scientific synopsis
start of 1:1-Block forwarded Data

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

[---]*

end of 1:1-Block forwarded Data
start of 1:1-Block forwarded Data Content

Description IPD sharing plan:

[---]*

end of 1:1-Block forwarded Data Content
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00014925
  •   2018/07/12
  •   [---]*
  •   yes
  •   Approved
  •   179/18 , Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  •   U1111-1217-0075 
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   E66.0 -  Obesity due to excess calories
end of 1:N-Block indications
start of 1:N-Block interventions

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)
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Other
  •   Crossover
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

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

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

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).

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • University Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2018/07/30
  •   20
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

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.

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

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.

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitätsklinikum Freiburg
    • Hugstetter Strasse 49
    • 79095  Freiburg
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Klinik für Anästhesiologie und Intensivmedizin Universitätsklinikum Freiburg
    • Mr.  Prof. Dr. rer. nat.  Stefan  Schumann 
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Klinik für Anästhesiologie und Intensivmedizin Universitätsklinikum Freiburg
    • Mr.  Prof. Dr. rer. nat.  Stefan  Schumann 
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Europäische Kommission Förderprogramm Horizont 2020
    • 1047  Brüssel
    • Belgium
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting complete, follow-up complete
  •   2018/10/23
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.