Trial document




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  DRKS00007741

Trial Description

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Title

Nasal versus oro-nasal mask during High-intensity-NPPV in COPD

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Noninvasive home mechanical has an increasing impact on treatment of chronic obstructive pulmonary disease.
A recent study revealed beneficial effects of home mechanical ventilation concerning long-term survival in patients witch chronic obstructive pulmonary disease if high ventilation preassures were applicated.
However, which type of mask should be used is unknown so far.
The aim of this study is to investigate the influence of nasal versus oro-nasal masks on quality of sleep and ventialtion as well as individual therapy accaptence.
To address that, patients with chronic hypercapnic obstructive pulmonary disease patientes already treated witch home mechanical ventialation will be studied in two consecutive nights. The use of oronasal- vs nasal mask will be switched after one night and monitored be sleep diagnostic tools.

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Brief Summary in Scientific Language

Noninvasive mechanical ventilation (NPPV) is an established treatment option in chronic hypercapnic respiratory failure with increasing user numbers. A recent study revealed benefitial effects of NPPV on long-term survival in patients with chronic obstructive pulmonary disease under high ventilation pressures with assited-controled ventilation modus, so called High-Intensity-NPPV (Hi-NPPV). The interface plays a crucial role in patients therapy acceptance and ventilation quality. The role of interface and the choice of oronasal vs. nasal mask and its influence on sleep and ventilation quality in Hi-NPPV in unknown so far.
In a randomised, cross-over trial patients already receiving NPPV due to chronic hypercapnic COPD will be evaluated in two consecutive nights. The interface is chosen in randomised order, oronasal vs nasal mask. In the second night, will be switched to the other interface. Polysomnographic and blood gas analysis will be performed to evaluate sleep and ventilation quality as well as individual acceptance by questionnaire. Sleep quality is the primary endpoint, compairing oronasal vs. nasal mask.

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Organizational Data

  •   DRKS00007741
  •   2015/03/17
  •   [---]*
  •   yes
  •   Approved
  •   181/2014, Ethik-Kommission der Universität Witten/Herdecke
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Secondary IDs

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Health Condition or Problem studied

  •   J44.9 -  Chronic obstructive pulmonary disease, unspecified
  •   J96.11 -  [generalization J96.1: Chronic respiratory failure]
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Interventions/Observational Groups

  •   Patients receiving High-Intensity-NPPV due to chronic hypercapnic COPD will be ventilated by nasal mask interface over one night. Polysomnographic recordings as well as capillary blood gas analysis will be performed.
    Individual acceptance is evaluated by a questionnaire.
  •   Patients receiving High-Intensity-NPPV due to chronic hypercapnic COPD will be ventilated by oronasal mask interface over one night. Polysomnographic recordings as well as capillary blood gas analysis will be performed.
    Individual acceptance is evaluated by a questionnaire.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Crossover
  •   N/A
  •   N/A
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Primary Outcome

sleepefficiency (as sleeptime/bedtime * 100)

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Secondary Outcome

quality of ventilation defined by alveolar ventilation represented by mean transcutaneous PCO2 and capillary blood gases (pO2, pCO2);
acceptence of ventialltion, evaluated by individual questionnaire;
leakages meassured by individual questionnaire as well as readout of built-in software of mechanical ventilators, duration of ventilation

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2015/04/01
  •   28
  •   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

home mechanical ventilation for at least a month ;
written consent ;
stable state of illness ;
stable blood gases (pH > 7,35 on the date) ;
underlying condition: COPD GOLD III-IV ;
High-Intensity NPPV ;
minimal IPAP of 22 mbar

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Exclusion Criteria

last hospitalization because of acute clinical deterioration during the last month;
deafness ;
mental retardation ;
lack of written consent ;
obesity (BMI > 35)

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Lungenklinik Köln-MerheimKliniken der Stadt Köln gGmbH
    • Mr.  Prof. Dr. med.  Wolfram  Windisch 
    • Ostmerheimer Strasse 200
    • 51109  Köln
    • Germany
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    • Lungenklinik MerheimKliniken der Stadt Köln gGmbH
    • Mr.  PD Dr.med.  Jan Hendrik  Storre 
    • Ostmerheimer Str. 200
    • 51109  Köln
    • Germany
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    • Lungenklinik MerheimKliniken der Stadt Köln gGmbH
    • Mr.  PD Dr.med.  Jan Hendrik  Storre 
    • Ostmerheimer Str. 200
    • 51109  Köln
    • Germany
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Sources of Monetary or Material Support

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    • Lungenklinik Köln-MerheimKliniken der Stadt Köln gGmbH
    • Mr.  Prof. Dr. med.  Wolfram  Windisch 
    • Ostmerheimer Strasse 200
    • 51109  Köln
    • Germany
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    • VitalAire GmbH
    • Bornbach 2
    • 22848  Norderstedt
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.