Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00012639

Trial Description

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Title

prospective observational study to evaluate transpulmonary pressure, end expiratory lung volume and intraabdominal pressure in mechanical ventilated patients

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Trial Acronym

[---]*

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URL of the Trial

http://keine

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Brief Summary in Lay Language

[---]*

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Brief Summary in Scientific Language

We will measure transpulmonary pressure, end expiratorisch lung volume and abdominal pressure in adult intensive care medicine patients. Thru this Parameter an individual Approach for mechanical Ventilation should be implemented

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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

  •   DRKS00012639
  •   2017/07/12
  •   [---]*
  •   yes
  •   Approved
  •   S-579/2016, Ethik-Kommission I der Medizinischen Fakultät Heidelberg
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Secondary IDs

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

  •   J80.09 -  [generalization J80: Adult respiratory distress syndrome]
  •   J44.99 -  [generalization J44.9: Chronic obstructive pulmonary disease, unspecified]
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Interventions/Observational Groups

  •   measurement of transpulmonary pressure, end expiratory lung volume and intraabdominal pressure at a PEEP Level of 15, 10 an 5 cm of water in mechanical ventilated intensive care patients
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Characteristics

  •   Interventional
  •   [---]*
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Basic research/physiological study
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Aim of the study is to measure transpulmonary pressure, end expiratory lung volume and intraabdominal pressure at three different PEEP levels

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Secondary Outcome

analysis of individual respiratory management

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2017/03/15
  •   60
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

1. mechanical ventilated patients
2. Age > 18 years
3. consent

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Exclusion Criteria

1. no consent
2. measurement sof IAP, Ptp or EELV not possible
3. physicians decision that Intervention may to riscful for the patient

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Addresses

  • start of 1:1-Block address primary-sponsor
    • KKH BergstrasseAbteilung Anästhesie/Intensivmedizin
    • Mr.  PD Dr. med.  Armin  Kalenka 
    • Viernheimer Str 2
    • 64646  Heppenheim
    • Germany
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    • KKH BergstrasseAbteilung Anästhesie/Intensivmedizin
    • Mr.  PD Dr. med.  Armin  Kalenka 
    • Viernheimer Str 2
    • 64646  Heppenheim
    • Germany
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    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • KKH BergstrasseAbteilung Anästhesie/Intensivmedizin
    • Mr.  PD Dr. med.  Armin  Kalenka 
    • Viernheimer Str 2
    • 64646  Heppenheim
    • Germany
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Sources of Monetary or Material Support

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    • KKH BergstrasseAbteilung Anästhesie/Intensivmedizin
    • Mr.  PD Dr. med.  Armin  Kalenka 
    • Viernheimer Str 2
    • 64646  Heppenheim
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2019/07/12
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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.