Trial document




drksid header

  DRKS00004325

Trial Description

start of 1:1-Block title

Title

Intratidal nonlinear mechanics of the respiratory system during anesthesia for laparoscopic surgery

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 laparoscopic surgery patients are mechanically ventilated. For allowing a better view for the surgeon, the abdomen is inflated by pressurized gas. During this time pressure is measured in the respiratory system to clalculate later the respiratory system mechanics. In this context "nonlinear" means that the mechanics may change with ventilation pressure.
The aim of this study is to investigate how the intraabdominal pressure effects the respiratory system mechanics.

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

Brief Summary in Scientific Language

In a recent study [1] it was demonstrated in patients with acute lung injury, that setting the positive end expiratory pressure (PEEP) guided by the esophageal pressure resulted in several improved diagnostic parameters. This study aims at investigating the physiological backgound in patents with healthy lungs. Therefore, the pressure-volumen relationship and thereby the nonlinear dynamic compliance profile [2] of the respiratory system will be analyzed in its dependecy from intraabdominal pressure. In this context the pneumoperitoneum is the model for an increased intraabdominal pressure at unchanges mechanical properties of the lung tissue.
[1] Talmor et al. Mechanical ventilation guided by esophageal pressure in acute lung injury. N Engl J Med. 2008 Nov 13;359(20):2095-104.
[2] Schumann et al. Analysis of Dynamic Intratidal Compliance in a Lung Collapse Model. Anesthesiology 2011;114(5):1111-1117.

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

Organizational Data

  •   DRKS00004325
  •   2012/08/21
  •   [---]*
  •   yes
  •   Approved
  •   67/12, 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

  •   respiratory system mechanics of patients during laparoscopic surgery
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Study group: patients without lung injury during elective laparoscopic surgery
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Diagnostic
  •   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 aiirwa pressure, flow rate, esophageal and gastric pressure are recorded. In an offline analysis the intratidal compliance course will be calculated.

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

Secondary Outcome

During the experiment oxygenation will be recorded. The data alalysis will be performed after the experiment.

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
  •   2012/11/21
  •   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 withou lung injury during laparoscopic 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, 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 Freiburg
    • Mr.  Dr.  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
    • Anästhesiologische Universitätsklinik Freiburg
    • 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
  •   2013/01/25
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.