Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00000639

Trial Description

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Title

Effects of high-intensity noninvasive positive pressure ventilation on minute ventilation in stable hypercapnic COPD

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Trial Acronym

[---]*

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URL of the Trial

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Brief Summary in Lay Language

Non invasive ventilation is well-established in the treatment of chronic ventilatory failure due to chronic obstructive pulmonary disease. It has been shown that non-invasive ventilation is able to improve gas exchange, pulmonary function, health-related quality of life and exercise capacity.
In general there are two different modes of ventilation: volume controlled ventilation and pressure controlled ventilation. To date, pressure controlled ventilation is predominantly used for the treatment of chronic respiratory failure.
Recently, so called hybrid modes were established for noninvasive ventilation, combining pressure- and volume-controlled ventilation. To maintain a preset target volume the ventilator is able to adjust the inspiratory pressure within a preset range.
The aim of the present study is to compare respiratory volumes, respiratory pressures and respiratory rates during spontaneous breathing and during noninvasive ventilation with different ventilation modes.

Pneumotachographic measurements are performed for 10 minutes each using the following settings:

1. during spontaneous breathing
2. during noninvasive ventilation with the patients own ventilator
3. during noninvasive ventilation using a new ventilator (Stellar 150, Resmed) with original ventilator settings
4. during noninvasive ventilation using a hybrid mode (iVAPS, Stellar 150, Resmed)

Potential study participants are patients suffering from chronic respiratory insufficiency due to chronic obstructive pulmonary disease receiving non-invasive ventilation for at least 2 months.


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Brief Summary in Scientific Language

Non invasive ventilation is well-established in the treatment of chronic ventilatory failure due to chronic obstructive pulmonary disease. It has been shown that non-invasive ventilation is able to improve gas exchange, pulmonary function, health-related quality of life and exercise capacity.
In general there are two different modes of ventilation: volume controlled ventilation and pressure controlled ventilation. To date, pressure controlled ventilation is predominantly used to treat chronic respiratory failure.
Recent studies showed a similar effect on gas exchanges and quality of sleep when comparing volume- and pressure-controlled ventilation.
There are hybrid modes on the market combining pressure- and volume-controlled ventilation. To maintain a preset target volume the ventilator adjusts the inspiratory pressure in a preset pressure range. A recent study showed a good acceptance of that mode and even an improvement of nocturnal gas exchange using that hybrid mode.
The aim of the present study is to compare respiratory volumes, respiratory pressures and respiratory rates during spontaneous breathing and during noninvasive ventilation with different modes using a pneumotachograph.
Pneumotachographic measurements are performed for 10 minutes each using the following settings:

1. during spontaneous breathing
2. during noninvasive ventilation with the patients own ventilator
3. during noninvasive ventilation using a new ventilator (Stellar 150, Resmed) with original ventilator settings
4. during noninvasive ventilation using a hybrid mode (iVAPS, Stellar 150, Resmed)

Potential study participants are patients suffering from chronic respiratory insufficiency due to chronic obstructive pulmonary disease receiving non-invasive ventilation for at least 2 months.

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Organizational Data

  •   DRKS00000639
  •   2011/01/17
  •   [---]*
  •   yes
  •   Approved
  •   277/10, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

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

  •   J96.1 -  Chronic respiratory failure
  •   J44.81 -  [generalization J44.8: Other specified chronic obstructive pulmonary disease]
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Interventions/Observational Groups

  •   spontaneous breathing
  •   ventilation with own ventilator
  •   ventilation with Stellar 150, Resmed using original ventilator settings
  •   ventilation with iVAPS mode
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Characteristics

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

minute ventilation during different modes of ventilation measured with pneumotachograph

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Secondary Outcome

respiratory rate, ventilation pressure

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2010/09/09
  •   30
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

patients with chronic respiratory failure using noninvasive ventilation for more than 2 months

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Exclusion Criteria

acute exazerbation (> 2 of the following signs: infiltrates in chest x-ray, increase of CRP or leukocytes, yellow or green sputum, fever

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitätsklinik Freiburg, Abeilung Pneumologie
    • Mr.  Dr.med.  Michael  Dreher 
    • Kilianstr.5
    • 79106  Freiburg
    • Germany
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    • Universitätsklinik Freiburg, Abeilung Pneumologie
    • Mr.  Dr.med.  Michael  Dreher 
    • Kilianstr.5
    • 79106  Freiburg
    • Germany
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    • Universitätsklinik Freiburg, Abteilung Pneumologie
    • Ms.  Dr.med.  Emelie  Ekkernkamp 
    • Kilianstr.5
    • 79102  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinik Freiburg, Abeilung Pneumologie
    • Mr.  Dr.med.  Michael  Dreher 
    • Kilianstr.5
    • 79106  Freiburg
    • Germany
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    • Firma Resmed
    • Fraunhoferstr.16
    • 82152  Martinsried
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2011/09/10
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Trial Publications, Results and other Documents

  •   Abstract
  •   doi: 10.3109/15412555.2013.829437
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* This entry means the parameter is not applicable or has not been set.