Trial document




drksid header

  DRKS00005058

Trial Description

start of 1:1-Block title

Title

Effects of respiratory system mechanics / ventilation at increasing of positive end-expiratory pressure in lung-healthy patients during elective surgeries with anesthesia

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

Trial Acronym

[---]*

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

During surgical interventions patients are mechanically ventilated by an anaesthetic machine. During this time, the pressure inside the respiratory system shall be measured to enable the analysis of respiratory system mechanics retrospectively. During the mesurement, the positive end-expiratory pressure will we increased in two steps.
Target of this study is to investigate how respiratory system mechanics change due to positive end-expiratory pressure increases.

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

Brief Summary in Scientific Language

The analysis of the ventilatory situation of ventilated patients with healthy lungs is widely unattended. We want to measure respiratory system mechanics in patients without lung injury who are ventilated during anaesthesia. We want to investigate, on which part of the nonlinear dynamic compliance [1] curve are ventilated and how respiratory system mechanics change as response of an increase in positive end-expiratory pressure (PEEP). For data analysis we will use the glidingSLICE technique [2,3]. Furthermore, using electrical impedance tomography we want to find out how the gas distribution in the lungs changes with increasing PEEP.

[1] Guttmann et al. Determination of volume-dependent respiratory system mechanics in mechanically ventilated patients using the new SLICE method Technology und Health Care, 2 (1994) 175-191
[2] Schumann et al. Estimating intratidal nonlinearity of respiratory system mechan-ics: a model study using the enhanced gliding-SLICE Method Physiol Meas 2009 Dec; 30:1341-1356.
[3] Schumann et al. Analysis of dynamic intratidal compliance in a lung collapse model. Anesthesiology 2011 May;114(5):1111-1117.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00005058
  •   2013/06/10
  •   [---]*
  •   yes
  •   Approved
  •   130/13, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   patients during surgery
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Observational group: In patients with no known lung injury during mechanical ventilation for elective surgery respiratory system mechanics ans ventilation distribution in the lungs are investigated on different levels of positive end-expiratory pressure.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Other
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Basic research/physiological study
  •   Single (group)
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

The temporal courses of pressure and flow rate are recorded as measured from the ventilator. After the experiments the intratidal profile of compliance is calculated from these data in an offline analysis.

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

Secondary Outcome

Using a device for electical impedance tomography the impedacnes inside the thorax are measured. In an offline analysis the ventilation distribution in the lungs will be determined.

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
  •   2013/06/12
  •   30
  •   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

patients with non-injured lungs during surgery

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

Exclusion Criteria

pregnancy, known lung injury, terminal state of desease, unstable spinal injury, pacemakre, implanted cardioverter of defibrillator, brain injury, congenital heart defect, missing confirmed consent

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

Addresses

  • start of 1:1-Block address primary-sponsor
    • Anästhesiologische Universitätsklinik Freiburg
    • Mr.  Dr.  Stefan  Schumann 
    • Hugstetter Str. 55
    • 79106  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
    • Anästhesiologische Universitätsklinik Freiburg
    • Mr.  Dr.  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
    • Anästhesiologische Universitätsklinik
    • Mr.  Dr.  Steffen  Wirth 
    • 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
    • Anästhesiologische Universitätsklinik Freiburg
    • Mr.  Dr.  Stefan  Schumann 
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
    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
  •   2013/08/30
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  •   Intraoperative compliance profiles and regional lung ventilation improve with increasing positive end-expiratory pressure. Wirth S, Kreysing M, Spaeth J, Schumann S. Acta Anaesthesiol Scand 2016 Oct;60(9):1241-1250.
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.