Intelligent Volume Assured Pressure Support to Improve Sleep Quality and Respiratory Events in Patients With Non Invasive Ventilation
Condition: COPD; Chronic Hypercapnic Respiratory Failure
MeSH terms: Respiratory Insufficiency; Hypercapnia
Study type: Interventional

Summary: 
      Aim of this prospective randomized trial is to compare non invasive ventilation (NIV) with
      pressure control (BiPAP-ST) to volume assured pressure support (iVAPS) with regards to sleep
      quality and alveolar ventilation in patients with routine NIV initiation after COPD
      exacerbation.

      20 patients with COPD and chronic hypercapnic respiratory failure will spent two nights on
      NIV, one with spontaneous timed pressure controlled bilevel ventilation (BiPAP-ST) and one
      with the advanced mode of intelligent volume assured pressure support (iVAPS). Patients will
      spend the treatment nights in randomized order under polysomnographic surveillance, including
      transcutaneous PCO2 measurement. Besides the number of arousals and PCO2 values over night
      the sleep quality will be judged with regards to especially adjusted respiratory event
      criteria like unintentional leaks, patient ventilator asynchrony, and decrease of ventilatory
      drive.
    

Detailed description: 
      Non invasive ventilation (NIV) is one of the major medical innovations of the last 30 years.
      Especially continuous positive airway pressure (CPAP) is the established Gold Standard in
      obstructive sleep apnea (OSA) treatment.

      NIV with bilevel ventilation (BiPAP-ST) is the established Gold Standard in acute hypercapnic
      respiratory failure, especially in exacerbated COPD.

      Still, the adaption of CPAP in OSA is less complicated than a bilevel therapy in hypercapnic
      failure. The adjustment of NIV requires not only the definition of expiration pressure (PEEP)
      but also of inspiration pressure support. Only adequate pressure difference guarantees
      effective ventilatory assistance and an improvement of alveolar ventilation. The pressure
      changes need to be defined by the physician, as well as the breathing frequency.

      Ventilation can furthermore be controlled by a target volume (volume controlled) or a target
      pressure (pressure controlled).

      Moreover, patients with respiratory insufficiency are often suffering of significant dyspnoea
      and are hard to accustom to a respiratory mask.

      There is a lack of systematic studies addressing the effects of different ventilator settings
      on sleep and life quality, as well as studies about the necessary monitoring extent during
      the NIV initiation.
    

Intervention name(s): pressure controlled ventilation BIPAP ST; volume assured pressure support IVAPS; NIV
Intervention type(s): Device; Device; Device
Intervention description(s): spontaneous timed pressure controled bilevel ventilation; intelligent volume assured Pressure Support; Patients with COPD and chronic hypercapnic respiratory failure will spent two nights on NIV, one with spontaneous timed pressure controlled bilevel ventilation (BiPAP ST) and one with the advanced mode of intelligent volume assured pressure support (IVAPS). Patients will spend the treatment nights in randomized order under polysomnographic surveillance, including transcutaneous PCO2 measurement.
Other intervention name(s): Stellar™ 150, ResMed; Stellar™ 150 with iVAPS; Stellar™ 150, ResMed
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: COPD; chronic hypercapnic respiratory failure; NIV; respiratory events; IVAPS