Trial document





This trial has been registered retrospectively.
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  DRKS00004434

Trial Description

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Title

Computerised automatic lung CT region-of interest analysis and segmentation / Auto-ROI study

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

The development of a new software algorithm allows for automatic lung CT analysis in ARDS patients (acute lung failure). This enables clinicians to institute changes to medical therapy in response to the clinical data generated by this new algorithm.
All patients with ARDS can be included in this study. The main question we hope to answer with this study is whether the automatic segmentation and lung analysis is as accurate and faster than conventional manual analysis and segmentation of lung CTs.

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Brief Summary in Scientific Language

Computerised tomography (CT) of the lung region of interest analysis (Auto-ROI) offers clinicians an opportunity to rapidly analyse lung morphology. Using automated ROI algorithms, it is possible to analyse a whole lung CT within few seconds. It is thus possible to quantify various degrees of lung aeriation and consolidation in healthy and diseased lungs. This technique is especially promising in regards to changes induced by altering PEEP levels in order to recruit previously atelectatic lung regions. Possible areas of lung overdistension by high PEEP levels could thus be detected and help reduce ventilator associated lung injury.

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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

  •   DRKS00004434
  •   2012/10/04
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  •   yes
  •   Approved
  •   15/04/2012, Ethik-Kommission der Medizinischen Fakultät der Georg-August-Universität Göttingen
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Secondary IDs

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Health Condition or Problem studied

  •   ARDS
  •   J80 -  Adult respiratory distress syndrome
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Interventions/Observational Groups

  •   only one arm since study is an observational study.
    All patients with ARDS and a lung CT scan can be recruited into the study. Automatic and manual lung CT analyses are performed and results compared.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Diagnostic
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Accuracy of analysis: a comparison between manually analysed data and automotically generated data is being made. Apart from lung density, lung aereation, amount of overdistended lung tissue, amount of atelectatic lung areas and others are being compared.

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Secondary Outcome

Speed of analysis

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2012/05/28
  •   20
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   120   Years
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Additional Inclusion Criteria

ARDS (acute)
Consent to study given
Lung CT scan performed before study recruitment

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Exclusion Criteria

lack of consent
preexisting severe lung disease (COPD, asthma)
gravidity

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Addresses

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    • ZARI , UMG Göttingen
    • Mr.  Dr. med.  Onnen  Mörer 
    • Robert-Koch-Str. 40
    • 37099  Göttingen
    • Germany
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    • ZARI , UMG Göttingen
    • Mr.  Dr. med.  Onnen  Mörer 
    • Robert-Koch-Str. 40
    • 37099  Göttingen
    • Germany
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    • ZARI , UMG Göttingen
    • Mr.  Dr. med.  Onnen  Mörer 
    • Robert-Koch-Str. 40
    • 37099  Göttingen
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsmedizin Göttingen Zentrum Anaesthesiologie, Rettungs- und Intensivmedizin
    • Robert-Koch-Straße 40
    • 37099  Göttingen
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.