Trial document
DRKS00007741
Trial Description
Title
Nasal versus oro-nasal mask during High-intensity-NPPV in COPD
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.
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.
Do you plan to share individual participant data with other researchers?
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Description IPD sharing plan:
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Organizational Data
- DRKS00007741
- 2015/03/17
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- yes
- Approved
- 181/2014, Ethik-Kommission der Universität Witten/Herdecke
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]
Interventions/Observational Groups
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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.
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
Primary Outcome
sleepefficiency (as sleeptime/bedtime * 100)
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
Countries of Recruitment
- Germany
Locations of Recruitment
- Medical Center
Recruitment
- Actual
- 2015/04/01
- 28
- Monocenter trial
- National
Inclusion Criteria
- Both, male and female
- 18 Years
- no maximum age
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
Exclusion Criteria
last hospitalization because of acute clinical deterioration during the last month;
deafness ;
mental retardation ;
lack of written consent ;
obesity (BMI > 35)
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
end of 1:1-Block address primary-sponsorstart of 1:1-Block address contact primary-sponsor- +49-(0)221-8907-18929
- +49-(0)221-8907-8305
- windischw at kliniken-koeln.de
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end of 1:1-Block address contact primary-sponsor -
start of 1:1-Block address scientific-contact
- Lungenklinik MerheimKliniken der Stadt Köln gGmbH
- Mr. PD Dr.med. Jan Hendrik Storre
- Ostmerheimer Str. 200
- 51109 Köln
- Germany
end of 1:1-Block address scientific-contactstart of 1:1-Block address contact scientific-contact- +49221890718344
- +4922189078305
- storrej at kliniken-koeln.de
- http://www.kliniken-koeln.de/Merheim_Lungenklinik_Startseite.htm?ActiveID=1041
end of 1:1-Block address contact scientific-contact -
start of 1:1-Block address public-contact
- Lungenklinik MerheimKliniken der Stadt Köln gGmbH
- Mr. PD Dr.med. Jan Hendrik Storre
- Ostmerheimer Str. 200
- 51109 Köln
- Germany
end of 1:1-Block address public-contactstart of 1:1-Block address contact public-contact- +49221890718344
- +4922189078305
- storrej at kliniken-koeln.de
- http://www.kliniken-koeln.de/Merheim_Lungenklinik_Startseite.htm?ActiveID=1041
end of 1:1-Block address contact public-contact
Sources of Monetary or Material Support
-
start of 1:1-Block address materialSupport
- Lungenklinik Köln-MerheimKliniken der Stadt Köln gGmbH
- Mr. Prof. Dr. med. Wolfram Windisch
- Ostmerheimer Strasse 200
- 51109 Köln
- Germany
end of 1:1-Block address materialSupportstart of 1:1-Block address contact materialSupport- +49-(0)221-8907-18929
- +49-(0)221-8907-8305
- windischw at kliniken-koeln.de
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end of 1:1-Block address contact materialSupport -
start of 1:1-Block address otherSupport
- VitalAire GmbH
- Bornbach 2
- 22848 Norderstedt
- Germany
end of 1:1-Block address otherSupportstart of 1:1-Block address contact otherSupport- [---]*
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end of 1:1-Block address contact otherSupport
Status
- Recruiting ongoing
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Trial Publications, Results and other Documents
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