The Effects of Airtrapping on Sleep and Breathing in Non Invasive Ventilation (NIV) in COPD

Study Overview
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Brief Summary
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15 COPD patients will be surveyed in this prospective randomized crossover pilot study concerning non invasive ventilation. Patients will be treated over 2 nights in randomized order with Ventimotion2 (Weinmann) with and without Airtrap Control under Polysomnography (PSG) surveillance including transcutaneous pCO2 measurement. The sleep quality is judged by evaluating the PSG and pCO2 values over night. Target parameters are respiratory rate, sleep quality and influence of Airtrap Control on pCO2 values over night.

Official Title
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German: Einfluss Von Airtrapping Auf Atmung Und Schlaf Bei Nichtinvasiver Beatmung (NIV) Von COPD Patienten

Conditions
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COPD, Hypercapnic Respiratory Failure

Intervention / Treatment
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* Device: BIPAP ST
* Device: Airtrap


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Stable respiratory situation Clinically required NIV Capable of giving consent Exclusion Criteria: Invasive ventilation Any other severe physical disease that requires immediate medical assistance Acute hypercapnic decompensation with pH <7.30 in routine BGA Circumstances that doesn't allow mask ventilation (e.g. facial deformation) Participation in a clinical trial within the last 4 weeks Pregnancy or nursing period Drug addiction

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: bilevel ventilation BIPAP ST<br>one night, BIPAP ST ventilation with individually optimised pressure parameters and supplemental oxygen if necessary. | Device: BIPAP ST<br>* non invasive ventilation, individually titrated for each patient, if necessary combined with oxygen, to improve hypercapnic respiratory failure.<br>* Other names: Ventimotion 2;|
| Experimental: BIPAP ST plus Airtrap<br>one night, BIPAP ST ventilation with Airtrap control, same pressure parameters and oxygen. | Device: BIPAP ST<br>* non invasive ventilation, individually titrated for each patient, if necessary combined with oxygen, to improve hypercapnic respiratory failure.<br>* Other names: Ventimotion 2;Device: Airtrap<br>* Addional to the individally titrated BiPAP ventilation parameters the function AirTrap Control is added. AirTrap Control helps to prevent dynamic hyperinflation and makes it possible for VENTImotion 2 to automatically regulate to the best frequency and expiration time.<br>* Other names: Ventimotion 2, Weinmann;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| breathing frequency | breathing frequency measured with the flow signal of a polysomnography during non invasive ventilation over night | 2 nights | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mean pCO2 level | mean pCO2 level over night measured with a transcutanous pCO2 monitor (TOSCA) | 2 nights | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD, NIV, Airtrapping, Ventimotion2