BACKGROUND: Oxy-Gen lite, a recently developed combined electrolysis and fuel cell technology, de-novo generates oxygen with high purity for medical use from distilled water and room air. However, its use in patients with chronic respiratory failure has never been evaluated. OBJECTIVES: To test the clinical applicability and safety of Oxy-Gen lite technology, we enrolled 32 COPD patients with chronic hypoxemia and long-term oxygen therapy (LTOT) in a controlled, randomized, multicenter clinical trial. MATERIALS AND METHODS: Standard continuous oxygen therapy with a maximal flow rate of 2 L/min was tested against pulsatile oxygen delivery by Oxy-Gen lite. Oxygen saturation at seated-rest was recorded over 30 min and used as a primary read-out parameter. Oxygen saturation was also recorded during mild physical strain (speaking out loud) or overnight's sleep. RESULTS: Both methods of oxygen supply established oxygen saturations within the normal range (ie, upper plateau of the sigmoid oxyhaemoglobin dissociation curve) compared to breathing room air (p < 0.0001). Mean oxygen saturation under standard continuous oxygen flow or Oxy-Gen lite technology during rest, physical strain or sleep proved statistically equivalent (95%CI < 2.5% of reference saturation). CONCLUSION: The use of Oxy-Gen lite in COPD patients with hypoxemia and LTOT <= 2 L/min is safe and results in oxygen saturation comparable to standard oxygen therapy. There is evidence that this form of oxygen supply is not only functional during rest but also during mild physical strain or overnight's sleep. Low noise, energy- and overhead-costs are particular advantages of this technology.

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