Efficacy and Physiology of Nasal High Flow Therapy
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Pulmonary Disease, Chronic Obstructive
Study type: Interventional

Summary: 
      The effects of a nasal high-flow (NHF) therapy in patients with chronic obstructive
      hypercapnic respiratory failure are still not sufficiently known yet.

      The aim of this study is a step-by-step generation of physiological data about gas exchange
      and respiration under high flow therapy using a nasal cannula with an AIRVO 2 device to
      provide NHF, leading to an analysis of the effects of high flow on PCO2 levels, exercise
      capacity, quality of life and gas exchange in a long term home treatment compared to a
      standard low flow long term oxygen therapy (LOT).

      Hypothesis: NHF and LOT therapy show differences in measured mean overnight transcutaneous
      carbon dioxide partial pressure (PCO2) after four weeks of treatment.
    

Detailed description: 
      Stage 1: Respiratory Physiology. Aim of this Stage is to investigate the effects of nasal
      High Flow (NHF) therapy in patients in progressed stages of COPD, by measuring physiologic
      parameters like tidal volume, breathing frequency and expiratory PCO2 concentration.

      Stage 2: Efficacy of short term NHF. Aim of this Stage is to evaluate the efficacy of two
      flow rates (20 L/min and 35 L/min) regarding alveolar ventilation in overnight therapy. For
      this reason, patients will have two PSG sleep studies during their hospital stay, under 20
      L/min and 35 L/min NHF therapy in randomized order.

      Stage 3: Home Care monitoring. Aim of this Stage is to compare long term influences of NHF
      and LOT on PCO2 levels randomised crossover, 4 weeks each treatment.

      Stage 4: Long Term Home Care monitoring . Aim of this stage is the long term follow up (12
      month) of patients to examine the compliance of a sufficient NHF therapy. Patients will
      retain the NHF therapy if they are responders (PCO2 improvement in stage 3 of at least 2 mmHG
      with NHF versus LOT) and willing and able to use NHF and a patient log.

      All patients will be monitored for the next 12 month. After 6 month there will be a control
      phone call.
    

Intervention name(s): NHF therapy; Long term Oxygen Therapy (LOT)
Intervention type(s): Device; Other
Intervention description(s): AIRVO 2 device therapy is either a humidifier with integrated flow generator that delivers warmed and humidified respiratory gases to spontaneously breathing patients through a variety of patient interfaces. Flow rates up to 60 L/min are available to the user, depending on the patient interface and mode of operation.In this study, flow rates of 20 L/min and 35 L/min will be compared.; Oxygen will individually be added to NHF in order to achieve stable oxygen saturation by pulse oximetry (SpO2) values of 88% to 92%.
Other intervention name(s): AIRVO 2; myAIRVO 2; PT101; PT100; supplemental oxygen
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: high flow; COPD; AIRVO