Trial document




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  DRKS00013579

Trial Description

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Title

Feasibility study: Evaluation of methods for continuous pain assessment based on contactless recording of vital and activity parameters

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Trial Acronym

Optic Pain Score

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Invasive procedures can be associated with pain.
It is informative to monitor pain perception during interventions. Usually pain assessment is done by nurses or doctors to guide pain therapy. To assess the level of pain continously and contactless by the use of a camera-based algorithm and in conjunction with vital parameters would be another option to ease pain management. The use of such a video-System should be tested within this feasibility study. The data are analysed with regard to patterns of mimics in conjunction with vital signs and opposed the pain levels expressed by patients.

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Brief Summary in Scientific Language

Continuous and contactless technologies can ease pain monitoring and therefore improve pain therapy in the future. This requires the development of algorithms to evaluate patterns of mimics in conjunction with vital Parameters in a camera based System, which uses photoplethysmography.
Patiens undergoing selected EP-studies should be monitored with the camerasystem. It should be evaluated to what extent it is feasible to assess pain levels during the procedure with the camera based techonology. The Treatment is not affected by the camera-monitoring.

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Organizational Data

  •   DRKS00013579
  •   2017/12/12
  •   [---]*
  •   yes
  •   Approved
  •   083/17-ek, Ethikkommission an der Medizinischen Fakultät der Universität Leipzig
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Secondary IDs

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Health Condition or Problem studied

  •   I48.1 -  Persistent atrial fibrillation
  •   R52.0 -  Acute pain
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Interventions/Observational Groups

  •   Patients undergoing selected routine EP-studies with only mild or no sedation are evaluated. Vital Signs (heart frequency, blood pressure, oxygen saturation) and pain level mentioned by the patient (NRS (0-10) every 5 min are collected. Additionnally videosignals of the face are recorded throughout the intervention. Patients serve as their own controls.
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Characteristics

  •   Non-interventional
  •   Other
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Other
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Patterns of Mimics and vital Parameters derived with the help of the camera. Data are analysed and evaluated to what extent they can be used to assess pain Levels and develop a reliable pain score.

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Secondary Outcome

n/a

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2017/12/13
  •   30
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

Patients undergoing selected routine EP-studies with only mild or no sedation are evaluated.

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Exclusion Criteria

patients not fullfilling the above mentioned criteria as well as patients with cognitive impairments and severe presbyakusis.

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Addresses

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    • Herzzentrum Leipzig GmbH Klinik für Innere Medizin/Kardiologie Abteilung für Rhythmologie
    • Ms.  Dr. med.  Kerstin  Bode 
    • Strümpellstr. 39
    • 04289  Leipzig
    • Germany
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    • Hochschule für Technik, Wirtschaft und Kultur (HTWK) Leipzig, Laboratory for Biosignal Processing (LaBP)
    • Mr.  Dr.  Mirco  Fuchs 
    • Karl-Liebknecht-Straße 132
    • 04277  Leipzig
    • Germany
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    • Herzzentrum Leipzig GmbH Klinik für Innere Medizin/Kardiologie Abteilung für Rhythmologie
    • Ms.  Dr. med.  Kerstin  Bode 
    • Strümpellstr. 39
    • 04289  Leipzig
    • Germany
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    • Herzzentrum Leipzig GmbH Klinik für Innere Medizin/Kardiologie Abteilung für Rhythmologie
    • Ms.  Dr. med.  Kerstin  Bode 
    • Strümpellstr. 39
    • 04289  Leipzig
    • Germany
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Sources of Monetary or Material Support

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    • Leipzig Heart Institute GmbH
    • Trendelenburgstr. 16
    • 04289  Leipzig
    • 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.