Trial document





This trial has been registered retrospectively.
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  DRKS00000710

Trial Description

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Title

Continuous positive airway pressure during stair climbing in patients with very severe COPD

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Trial Acronym

[---]*

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URL of the Trial

[---]*

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Brief Summary in Lay Language

CPAP (continous positive airway pressure) is a way on non-invasive ventilation that is known to be benefitial in COPD patients during exercise to decrease dyspnea and dynamic lung hyperinflation.
In a previous study it has been shown that stair climbing is associated with excess dynamic lung hyperinflation, dyspnea and deoxigenation in severely affected COPD patients.
The rationale of this study is to test whether CPAP is feasible to treat stair-climbing induced dyspnea, lung hyperinflation and deoxigenation in severely affected oygen dependend COPD patients.

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Brief Summary in Scientific Language

Breathlessness and exercise limitation is believed to increase in chronic obstructive pulmonary disease (COPD) due to an augmented ventilatory load, reduced ventilatory capacity, dynamic hyperinflation and increased neuromechanical uncoupling leading to an elevation of respiratory drive and therefore to the perception of breathlessness cumulating in termination of exercise even during daily activities. In severe COPD-patients, stair climbing is known to be associated with prolonged dynamic lung hyperinflation, higher blood lactate levels and increased exercise related dyspnea when compared to walking. Therefore, stair climbing is suggested to be a major burden in COPD-patients and a facilitation of this common daily obstacle appearing in and beyond the home should be of major interest.
Continuous positive airway pressure (CPAP) has been shown to be beneficial to emphysematous COPD patients increasing inspiratory capacity at rest. Several studies investigated the use of CPAP applied during exercise in COPD-patients in order to overcome the intrinsic positive endexpiratory pressure (PEEP) by applying an extrinsic PEEP and thereby treating dynamic hyperinflation. The aim of the present study is to assess if CPAP applied during stair climbing prevents dynamic hyperinflation and thereby prevents exercise induced dyspnoea in oxygen-dependent COPD-patients.

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Organizational Data

  •   DRKS00000710
  •   2011/02/01
  •   [---]*
  •   no
  •   Approved
  •   412/08, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

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

  •   J44.19 -  [generalization J44.1: Chronic obstructive pulmonary disease with acute exacerbation, unspecified]
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Interventions/Observational Groups

  •   Stair climbing (44 steps) with oxygen support
  •   Stair climbing (44 steps) with oxygen support and CPAP-support (7 cm H2O)
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Characteristics

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

absolute difference in blood gas parameters (PaO2, PaCO2, pH) measured prior and post intervention

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Secondary Outcome

Reduktion of dynamic lung hyperinflation during exercise in COPD patients measured by spirometry prior and post the exercise; difference of dyspnea-sensation and limb discomfort as assessed by the Borg-Scale

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2008/12/01
  •   20
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Oxygen dependend COPD patients (GOLD III / IV)

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Exclusion Criteria

Hypercapnia, acute exacerbations (not more than 2 signs: radiological infiltration, infectious constellations in laboratory measures, coloured sputum, fever)

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Addresses

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    • Uniklinik Freiburg
    • Mr.  Dr.  Michael  Dreher 
    • Killianstr. 5
    • 79106   Freiburg
    • Germany
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    • Uniklinik Freiburg
    • Mr.  Dr.  Stephan  Walterspacher 
    • Killianstr. 5
    • 79106   Freiburg
    • Germany
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  • start of 1:1-Block address scientific-contact
    • Uniklinik Freiburg
    • Mr.  Dr.  Michael  Dreher 
    • Killianstr. 5
    • 79106   Freiburg
    • Germany
    end of 1:1-Block address scientific-contact
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    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Uniklinik Freiburg
    • Mr.  Dr.  Michael  Dreher 
    • Killianstr. 5
    • 79106   Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Philips-Respironics Inc.
    • 1501 Ardmore Boulevard
    • 15221-4451  Pitsburgh
    • United States
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Status

  •   Recruiting complete, follow-up complete
  •   2010/09/01
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Trial Publications, Results and other Documents

  •   Walterspacher S, Walker D, Windisch W, Dreher M (2013) Continuous positive airway pressure applied during stair climbing in patients with very severe COPD. COPD 10(2):193-9.
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* This entry means the parameter is not applicable or has not been set.