Trial document




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  DRKS00014330

Trial Description

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Title

Algorithmic Surveillance of ICU patients to improve personalized management of care

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Trial Acronym

ASIC

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URL of the Trial

http://www.smith.care/ziele/?lang=en

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Brief Summary in Lay Language

The patient data of mechanically ventilated ICU (Intensive care unit) patients will be better used to diagnose acute respiratory distress syndrome (ARDS) earlier, more acurate and to initialise a personalised therapy. The intended project aims to the treatment of ICU patients at risk for ARDS.

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Brief Summary in Scientific Language

By means of model-based, algorithmic surveillance and continuous monitoring, analysis of patient data of mechanically ventilated ICU patients will be performed. An app-based decision support system will support physicians to diagnose acute respiratory distress syndrome (ARDS) earlier. Through the analysis of large-scale data from patient data management systems (PDMS) and by the application of high performance computing a diagnostic expert advisor system will help to realize future personalised treatment of ICU patients. The intended project aims to enhance timely diagnosis and evidence-based treatment of ICU patients at risk for ARDS. The evaluation will be performed via stepped-wedge-design.

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Organizational Data

  •   DRKS00014330
  •   2019/05/24
  •   [---]*
  •   yes
  •   Approved
  •   EK 102/19, Ethik-Kommission an der Medizinischen Fakultät der RWTH Aachen
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   J80.01 -  [generalization J80: Adult respiratory distress syndrome]
  •   J80.02 -  [generalization J80: Adult respiratory distress syndrome]
  •   J80.03 -  [generalization J80: Adult respiratory distress syndrome]
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Interventions/Observational Groups

  •   TAU ("treatment as usual")
  •   By means of model-based, algorithmic surveillance and continuous monitoring, analysis of patient data of mechanically ventilated ICU patients will be performed. An app-based decision support system will support physicians to diagnose acute respiratory distress syndrome (ARDS) earlier. Through the analysis of large-scale data from patient data management systems (PDMS) and by the application of high performance computing a diagnostic expert advisor system will help to realize future personalised treatment of ICU patients. The intended project aims to enhance timely diagnosis and evidence-based treatment of ICU patients at risk for ARDS. The evaluation will be performed via stepped-wedge-design.
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Characteristics

  •   Non-interventional
  •   Other
  •   Other
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Other
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

Co-primary:
- Detection rate of ARDS (acute respiratory distress syndrome) and adherence to lung protective ventilation of patients with ARDS

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Secondary Outcome

- organ dysfunctions
- length of ICU (Intensive Care Unit) stay
- days on mechanical ventilation (MV): days off MV
- hospital / ICU readmissions
- technology (mobile devices) acceptance and usage

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
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Recruitment

  •   Planned
  •   2019/07/01
  •   6000
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

ICU (Intensive Care Unit) patients requiring mechanical ventilation for >24 hours

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Exclusion Criteria

moribund patients with life expectancy <48 hours

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Addresses

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    • Universitätsklinikum Aachen, AöR
    • Mr.  Univ.-Prof. Dr. med.  Gernot  Marx 
    • Pauwelsstraße 30
    • 52074   Aachen
    • Germany
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    • Universitätsklinikum der RWTH Aachen
    • Mr.  Univ.-Prof. Dr. med.  Gernot  Marx 
    • Pauwelsstraße 30
    • 52074  Aachen
    • Germany
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    • Universitätsklinikum der RWTH Aachen
    • Mr.  Univ.-Prof. Dr. med.  Gernot  Marx 
    • Pauwelsstraße 30
    • 52074  Aachen
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Bildung und Forschung Dienstsitz Berlin
    • Friedrichstraße 130 B
    • 10117  Berlin
    • Germany
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Status

  •   Recruiting planned
  •   [---]*
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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.