Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00004223

Trial Description

start of 1:1-Block title

Title

Evaluation of electrical impedance tomography to optimise mechanical ventilation in laparoscopic bariatric 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

Using a new technique to measure lung volume during surgery in obese patients to optimize mechanical ventilation. This study helps to increase safety in these patients during anaesthesia. Electrical impedance tomography is a new technique which allows the estimation of lung volumes during mechanical ventilation. This technique is non-invasive and measures differences in resistance in the skin during mechanical ventilation. There will be no additional strain on the patient. Anaesthesia will be much safer in these patients.

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

Brief Summary in Scientific Language

Electrical impedance measurement of lung volume in obese patients
Adjustment of airway pressure according to esophageal pressure measurement via a nasogastral probe

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

Organizational Data

  •   DRKS00004223
  •   2012/06/28
  •   [---]*
  •   yes
  •   Approved
  •   PV3867, Ethik-Kommission der Ärztekammer Hamburg
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

  •   E66.00 -  [generalization E66.0: Obesity due to excess calories]
  •   E66.20 -  [generalization E66.2: Extreme obesity with alveolar hypoventilation]
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Electrical impedance tomography measurement of lung volumes in patients undergoing bariatric surgery. Using an non-invasive measurement technique we will determine lung volumes in these patients during mechanical ventilation and adjust airway pressure according to esophageal pressure
  •   Institutional standard respirator setting; PEEP 10 mbar; monitoring using electrical impedance tomography (EIT) and esophageal pressure measurement
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

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

Primary Outcome

Lung volume measurement using electrical impedance tomography intra/during/post operative in bariatric surgery

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

Secondary Outcome

Measurement of oxygen saturation pre/intra/post operative using pulse oxymetry

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
  •   2012/05/28
  •   40
  •   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

Bariatric surgery

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

Exclusion Criteria

Children, smoker, preexisting lung disease/esophageal alterations

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

Addresses

  • start of 1:1-Block address primary-sponsor
    • Klinik für Anästhesiologie und IntensivmedizinUniversitätsklinikum Eppendorf/ Hamburg
    • Martinistr. 52
    • 20246  Hamburg
    • 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 und Poliklinik für Anästhesiologie Zentrum für Anästhesiologie und Intensivmedizin Universitätsklinikum Hamburg-Eppendorf
    • Mr.  Prof. Dr.  Christian  Zöllner 
    • Martinistr.
    • 20246  Hamburg
    • 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
    • Universitätsklinikum Hamburg Eppendorf Klinik und Poliklinik für Anästhesiologie
    • Mr.  Dr.  Lars  Eichler 
    • Martinistr.
    • 20246  Hamburg
    • 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
    • Dräger Medical Deutschland
    • Moislinger Allee 53-55
    • 23558  Lübeck
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   49 1805241318
    •   49 451 88272002
    •   [---]*
    •   [---]*
    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
  •   2013/03/25
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.