Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00000433

Trial Description

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Title

Transcutaneous should replace arterial PCO2 monitoring during nocturnal noninvasive ventilation

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Trial Acronym

[---]*

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Transcutaneous PCO2 (PtcCO2) monitoring gives the possibility to monitor the gas exchchange noninvasiley without a blood gas sample. The current study investigate this technique in patients treated by home mechanical ventilation and investiagte the technical limitation and accuracy compared to the invasive procedere of taking a blood gas sample. The study is performed during a sleep study in the hospital.

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Brief Summary in Scientific Language

Transcutaneous PCO2 (PtcCO2) monitoring combines the advantages of continuous and noninvasive PCO2 assessment, and this appears to be particularly adequate for nocturnal PCO2 measurement. However, the accuracy and reliability of nocturnal PtcCO2 assessment has yet not been established. Therefore, the study was aimed at assessing the accuracy of PtcCO2 monitoring and its technical drift during nocturnal NIV in patients with stable chronic respiratory failure.

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Organizational Data

  •   DRKS00000433
  •   2010/06/07
  •   2009/01/07
  •   yes
  •   Approved
  •   268/08, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

  •   UKF001774  (Register klinischer Studien des Universitätsklinikums Freiburg)
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Health Condition or Problem studied

  •   J00-J99 -  Diseases of the respiratory system
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Interventions/Observational Groups

  • [---]*
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Characteristics

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

Difference of technical drifts between all three transcutaneous PCO2-monitors (SenTec DM, TCM4-TINA and TOSCA500) after eight hours of nighttime monitoring.

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Secondary Outcome

Method comparison and correlation between transcutaneous and arterial pressures of carbon dioxide.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2008/08/26
  •   24
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

Cardio-respiratory stable patients with a pH >7,30 will be included. Patients will be studied during a clinical check up visit in the sleep unit of the Department of Pneumology, Univeristy Hospital Freiburg. Inclusion criteria are independent from the underlying disease causing ventilatory failure.

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Exclusion Criteria

Patients with evidence of acute respiratory failure (e.g. worsening symptoms during the last two weeks, a breathing frequency (fb) > 30/min, a pH < 7.35, or signs of respiratory infections) were excluded. In addition, obese patients with an BMI >35 kg/m2 will be excluded.

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitätsklinik Freiburg Innere Medizin V - Pneumologie
    • Mr.  Prof. Dr.  Wolfram  Windisch 
    • Killianstr. 5
    • 79106  Freiburg
    • Germany
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    • Universitätsklinik Freiburg Innere Medizin V - Pneumologie
    • Mr.  Dr.  Jan Hendrik  Storre 
    • Killianstr. 5
    • 79106  Freiburg
    • Germany
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    • Universitätsklinik Freiburg Innere Medizin V - Pneumologie
    • Mr.  Dr.  Jan Hendrik  Storre 
    • Killianstr. 5
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinik Freiburg Innere Medizin V - Pneumologie
    • Mr.  Prof. Dr.  Wolfram  Windisch 
    • Killianstr. 5
    • 79106  Freiburg
    • Germany
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    • SenTec AG
    • Ringstrasse 39
    • CH-4106   Therwil
    • Switzerland
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    • Radiometer GmbH
    • Linsellesstraße 142
    • D-47877  Willich
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2009/05/20
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Trial Publications, Results and other Documents

  •   http://www.resmedjournal.com/article/S0954-6111(10)00434-8/abstract
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* This entry means the parameter is not applicable or has not been set.