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Randomized Controlled Trial Multicenter Study
Oxygen generation by combined electrolysis and fuel-cell technology: clinical use in COPD patients requiring long time oxygen therapy.
- T O Hirche, T Born, S Jungblut, B Sczepanski, K Kenn, T Köhnlein, H Hirche, and T O Wagner.
- Department of Pulmonary Medicine, University Hospital Frankfurt, Theodor Stern Kai 7, 60590 Frankfurt, Germany.
- Eur. J. Med. Res. 2008 Oct 27; 13 (10): 451-8.
BackgroundOxy-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.ObjectivesTo 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 MethodsStandard 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.ResultsBoth methods of oxygen supply established oxygen saturations within the normal range (i.e., 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).ConclusionThe use of Oxy-Gen lite in COPD patients with hypoxemia and LTOT
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