Trial document




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  DRKS00011004

Trial Description

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Title

Monitoring of CO2 during percutaneous dilatational tracheostomy by transcutaneous measurement

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Trial Acronym

[---]*

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URL of the Trial

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Brief Summary in Lay Language

Percutaneous dilational tracheostomy is well established technique in intensive care medicine. Usually this technique to place a tracheostoma is performed by videobronchoscopy. The main disadvantage is the reduction of ventilation during the procedure leading to increased arterial CO2. During the trial CO2 will be measured percutaneously which should increase patient safety.

In the first part of the trial CO2 will be measured during mechanical ventilation with a tidalvolume of 6 ml/kg ideal bodyweight, in the second part with 12 ml/kg ideal body weight during intervention.

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Brief Summary in Scientific Language

Transcutaneous measurement of CO2 (SenTec Digital Monitor (SenTec AG; Therwil, Switzerland)) during percutaneous dilational tracheostomy

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Organizational Data

  •   DRKS00011004
  •   2016/09/20
  •   [---]*
  •   yes
  •   Approved
  •   101/2015, Ethik-Kommission der Universität Witten/Herdecke
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Secondary IDs

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Health Condition or Problem studied

  •   J44.1 -  Chronische obstruktive Lungenkrankheit mit akuter Exazerbation, nicht näher bezeichnet
  •   J80 -  Atemnotsyndrom des Erwachsenen [ARDS]
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Interventions/Observational Groups

  •   Observation: measurement of percutaneous CO2 during ventilation with 6 ml/kg ideal bodyweight during percutaneous dilational tracheostomy
  •   Intervention: measurement of percutaneous CO2 during ventilation with 12 ml/kg ideal bodyweight during percutaneous dilational tracheostomy
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Characteristics

  •   Interventional
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  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Basic research/physiological study
  •   Other
  •   IV
  •   N/A
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Primary Outcome

The primary endpoint is the measurement of the increase of CO2 by means of percutaneous measurement (SenTec Monitoring System, Switzerland). This values are validated by arterial CO2 measurement in blood gas analysis.

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Secondary Outcome

Increase of CO2 depending on the size of the tube.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2016/09/30
  •   56
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

intubated patients undergoing percutaneous dilational tracheostomy with a positive endexpiratory pressure of less than 15 cmH2O; sufficient oxygenation and pH>7.20

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Exclusion Criteria

pH<7.20, Percutaneous dilational tracheostomy not feasible, technical impossibility of percutaneous CO2 measurement, difference of percutaneous to arterial CO2 of more than 10%

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Lungenklinik Köln-Merheim
    • Mr.  Prof. Dr.  Wolfram  Windisch 
    • Ostmerheimer Str. 200
    • 51109  Köln
    • Germany
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    • Lungenklinik Köln-Merheim
    • Mr.  Prof. Dr.  Christrian  Karagiannidis 
    • Ostmerheimer Str. 200
    • 51109  Köln
    • Germany
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    • Lungenklinik Köln-Merheim
    • Ms.  Michaela Ludmilla  Merten 
    • Ostmerheimer Str. 200
    • 51109 Köln  Köln
    • Germany
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Sources of Monetary or Material Support

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    • Lungenklinik Köln-Merheim
    • Mr.  Prof. Dr.  Wolfram  Windisch 
    • Ostmerheimer Str. 200
    • 51109  Köln
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2017/11/16
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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.