Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00000449

Trial Description

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Title

Oxygenation during noninvasive ventilation: active valve- versus leak-circuit

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Trial Acronym

[---]*

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The current study investigates the impact of different ventilatory circuits in home mechanical noninvasive ventialtion. Here, differences could be expected by different expiratory valves and the impact of leaks during ventilation.

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Brief Summary in Scientific Language

The current study investigates the impact of different ventilatory circuits in home mechanical noninvasive ventialtion. Here, differences of oxygen fraction (FiO2) of the inhaled air are firstly analyzed in different ventilatory circuits. Secondly adding artificial leaks close to the face mask. Ventilator settings and supplemental oxygen flow are not changed analyzing the different study settups. Measurements are performed at daytime noninvasive ventilation in awake patients.

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Organizational Data

  •   DRKS00000449
  •   2010/10/05
  •   2010/10/05
  •   yes
  •   Approved
  •   319/09, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

  •   UKF002101  (Register klinischer Studien des Universitätsklinikums Freiburg)
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Health Condition or Problem studied

  •   J96.1 -  Chronic respiratory failure
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Interventions/Observational Groups

  •   active valve circuit with and without an artficial leak
  •   leak circuit with and without an artficial leak
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control
  •   Treatment
  •   Crossover
  •   N/A
  •   [---]*
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Primary Outcome

Difference of FiO2 at FiO2-sensor 2 (at the interface) between active valve circuit and leak circuit

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Secondary Outcome

Mean transcutaneous PCO2, oxygen saturation (SaO2), Subjective ventilation quality

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2009/12/11
  •   20
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

Patients with stable hypercapnic chronic respiratory failure (CRF) on NPPV with supplemental oxygen of at least 2 L/min will be enrolled. Patients are referred to the Department of Pneumology of the University Hospital Freiburg for a routine control visit of their NPPV.

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Exclusion Criteria

Patients who presented with an acute exacerbation (respiratory frequency 30 breaths/min, pH <7.35 or clinical signs of infection), those planned for weaning from invasive ventilation or those who had been intubated or tracheostomised during the previous 3 months will be excluded.

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Addresses

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    • Universitätsklinikum Freiburg, Abteilung 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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    • Universitätsklinikum Freiburg, Abteilung Innere Medizin V - Pneumologie
    • Mr.  Prof. Dr.  Wolfram  Windisch 
    • Killianstr. 5
    • 79106  Freiburg
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2010/08/05
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Trial Publications, Results and other Documents

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