Trial document




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  DRKS00011391

Trial Description

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Title

Respiratory disorders in severe CNS diseases

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Retrospective analysis of central disturbances of the regulation of breathing in severely ill neurological patients treated in the Evangelic Hospital Oldenburg (Evangelisches Krankenhaus Oldenburg) from 2014 until 2019

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Brief Summary in Scientific Language

Profound knowledge of pathologies of the central regulation of breathing is necessary for the safe and effective treatment of severely ill neurological patients. While some cases of secondary central hypoventilation syndromes have been published, literature on disturbed breathing patterns in patients remains sparse. In this case series we will analyse cases with pathologies of the central regulation of breathing, who were diagnosed from 2014 to 2019 in the Evangelic Hospital Oldenburg (Evangelisches Krankenhaus Oldenburg). Cases will be categorized as having secondary central hypoventilation syndrome, pathologic breathing patterns and/or primary central hyperventilation. Based on these data and on existing literature it is intended to present a model of pathologies of the central regulation of breathing, which should be prospectively evaluated as a second step.

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Do you plan to share individual participant data with other researchers?

Yes

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Description IPD sharing plan:

Email to martin.gross@evangelischeskrankenhaus.de

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Organizational Data

  •   DRKS00011391
  •   2019/06/11
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  •   yes
  •   Approved
  •   2019-050, Medizinische Ethikkommission der Carl von Ossietzky Universität Oldenburg
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Secondary IDs

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Health Condition or Problem studied

  •   sleep apnea
  •   secondary central hypoventilation syndrome
  •   G47.30 -  [generalization G47.3: Sleep apnoea]
  •   G47.32 -  [generalization G47.3: Sleep apnoea]
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Interventions/Observational Groups

  •   In this case series we will analyse cases with pathologies of the central regulation of breathing, who were diagnosed from 2014 to 2019 in the Evangelic Hospital Oldenburg (Evangelisches Krankenhaus Oldenburg). Cases will be categorized as having secondary central hypoventilation syndrome, pathologic breathing patterns and/or primary central hyperventilation. Based on these data and on existing literature it is intended to present a model of pathologies of the central regulation of breathing, which should be prospectively evaluated as a second step.
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Characteristics

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

Aim of the study is generating an integrative model of disturbed regulation of breathing in brain disease prior to planning a prospective study.

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Secondary Outcome

/

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2020/01/01
  •   10
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

Severe cerebral disease, Barthel-index <35 and disturbed regulation of breathing, diagnosed between 01/01/2014 and 31/12/2019

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Exclusion Criteria

No exclusion criteria

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Herr
    • Mr.  Dr.  Martin  Groß 
    • Steinweg 13
    • 26122  Oldenburg
    • Germany
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    • Evangelisches Krankenhaus Oldenburg
    • Mr.  Dr.  Martin  Groß 
    • Steinweg 13
    • 26122  Oldenburg
    • Germany
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    • Evangelisches Krankenhaus Oldenburg
    • Mr.  Dr.  Martin  Groß 
    • Steinweg 13
    • 26122  Oldenburg
    • Germany
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Sources of Monetary or Material Support

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    • Evangelisches Krankenhaus OldenburgKlinik für Neurologische Intensivmedizin und Frührehabilitation
    • Mr.  Dr.  Martin  Groß 
    • Steinweg 13-17
    • 26123  Oldenburg
    • 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.