Trial document




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  DRKS00012913

Trial Description

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Title

Is the usage of a mobile bilevel device capable of reducing dyspnea during exercise in patients with moderate to severe COPD?
– a randomized controlled trial

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

In this study patients with chronic obstructive lung disease (COPD) without already established non-invasive ventilation therapy should be examined. The aim is to examine whether an application of a mobile Ventilation device can lead to a reduction of dyspnea under load in COPD. The study participants carry out a standardized 6-minute walk test with or without the BiPAP device "VitaBreath". In order to achieve a high transferability on the patients daily life, all study participants can decide independently on the frequency and duration of the use of "VitaBreath".

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Brief Summary in Scientific Language

In a prospective, randomized, controlled crossover study patients with COPD Global Initiative for Chronic Obstructive Lung Disease (GOLD) III-IV without already established non-invasive ventilation therapy should be examined. The aim is to examine whether an application of a mobile BiPAP device can lead to a reduction of dyspnea under load in moderate to severe COPD. Depending on the randomization the study participants carry out a standardized 6-minute walk test with or without the BiPAP device "VitaBreath". In order to achieve a high transferability on the patients daily life, all study participants can decide independently on the frequency and duration of the use of "VitaBreath". Afterwards a cross-over takes place in the other group so that every participant can perform the 6-minute walk test once with and without the "VitaBreath". The primary objective is to show whether the use of "VitaBreath" results in a reduction of the exertional dyspnea during the 6-minute walk test.

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Organizational Data

  •   DRKS00012913
  •   2017/10/16
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  •   no
  •   Approved
  •   147/2017, Ethik-Kommission der Universität Witten/Herdecke
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Secondary IDs

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Health Condition or Problem studied

  •   J44.81 -  [generalization J44.8: Other specified chronic obstructive pulmonary disease]
  •   J44.80 -  [generalization J44.8: Other specified chronic obstructive pulmonary disease]
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Interventions/Observational Groups

  •   Standardized 6 Minute Walking Trial with the mobile BiPAP device VitaBreath. The frequency of the usage of VitaBreath can be decided by the user.
  •   Standardized 6 Minute Walking Trial without the mobile BiPAP device VitaBreath.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Control group receives no treatment
  •   Treatment
  •   Crossover
  •   N/A
  •   N/A
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Primary Outcome

Average difference of the Borg dyspnea scale before and after finishing the 6-minute walk test

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Secondary Outcome

- Results of the blood gas analysis after the 6-minute walk by Gyatt
- Walking distance
- Blood pressure after 6- Minute walk
- Vital capacity before and after 6-minute walk

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2018/02/19
  •   20
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

COPD stage III-IV
- definition by GOLD Guideline
- exclusion of a preexisting ventilation therapy
- exclusion of an acute exacerbation
- Signed declaration of consent
- Patients age >18 years

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Exclusion Criteria

- Patients age <18 years
- Mental retardation
- Missing declaration of consent
- Acute exacerbation of the disease
- Unsteady gait

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Addresses

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    • Philips Respironics
    • Murry Ridge Lane 1010
    • 15668  Murrysville
    • United States
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    • Kliniken der Stadt Köln gGmbH
    • Ostmerheimer Str. 200
    • 51109  Köln
    • Germany
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    •   0221890718929
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    • Kliniken der Stadt Köln gGmbH
    • Ms.  Dr  Sarah  Schwarz 
    • Ostmerheimer Str. 200
    • 51109  Köln
    • Germany
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    • Kliniken der Stadt Köln gGmbH
    • Ms.  Dr  Sarah  Schwarz 
    • Ostmerheimer Str. 200
    • 51109  Köln
    • Germany
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Sources of Monetary or Material Support

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    • Philips Respironics
    • Philips Respironics 
    • 1010 Murry Ridge Lane
    • 15668  Murrysville
    • United States
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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