The Effects of Airtrapping on Sleep and Breathing in Non Invasive Ventilation (NIV) in COPD
- Conditions
- Hypercapnic Respiratory FailureCOPD
- Registration Number
- NCT01987661
- Lead Sponsor
- Institut für Pneumologie Hagen Ambrock eV
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 10
- Stable respiratory situation
- Clinically required NIV
- Capable of giving consent
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method breathing frequency 2 nights breathing frequency measured with the flow signal of a polysomnography during non invasive ventilation over night
- Secondary Outcome Measures
Name Time Method mean pCO2 level 2 nights mean pCO2 level over night measured with a transcutanous pCO2 monitor (TOSCA)
Trial Locations
- Locations (1)
Helios Klinik Hagen
🇩🇪Hagen, NRW, Germany
Helios Klinik Hagen🇩🇪Hagen, NRW, Germany