Randomized crossover trial of a demand oxygen delivery system in nocturnal hypoxemia

• Published in: Scientific reports 2024-09, Vol.14 (1), p.20505-9, Article 20505
• Main Authors: Yatani, Atsuhiko, Nagano, Tatsuya, Murakami, Sae, Otoshi, Takehiro, Hazama, Daisuke, Katsurada, Naoko, Yamamoto, Masatsugu, Tachihara, Motoko, Nishimura, Yoshihiro, Kobayashi, Kazuyuki
• Format: Article
• Language: English
• Subjects: 631/443/1784; 692/699/1785; Adult; Aged; Auto-demand device; Chronic obstructive pulmonary disease; Chronic respiratory failure; Clinical trials; Cross-Over Studies; Ethics; Female; Heart failure; Home oxygen therapy; Humanities and Social Sciences; Humans; Hypoxemia; Hypoxia - therapy; Inhalation; Male; Middle Aged; multidisciplinary; Nighttime; Oxygen; Oxygen - administration & dosage; Oxygen - metabolism; Oxygen Inhalation Therapy - instrumentation; Oxygen Inhalation Therapy - methods; Oxygen Saturation; Oxygen therapy; Patients; Pneumonia; Respiration; Respiratory failure; Safety; Science; Science (multidisciplinary); Sleep; Stationary device
• ISSN: 2045-2322; 2045-2322
• DOI: 10.1038/s41598-024-71320-7

The newly developed portable oxygen concentrator with an auto-demand oxygen delivery system (auto-DODS) automatically switches between 3 sensitivities according to the negative pressure gradient of inhalation and supplies oxygen only during inhalation. The aim of this study was to verify the effectiveness and safety of auto-demand devices compared with a continuous flow oxygen concentrator, during sleep, in a randomized crossover noninferiority trial. We alternatively used an auto-DODS or a continuous-flow oxygen concentrator, all night on separate days for HOT (Home Oxygen Therapy) patients with nocturnal hypoxemic symptoms. The primary endpoints were the mean value of oxygen saturation (SpO 2 ) over the total sleep time. The secondary endpoints included the efficacy endpoints and the safety endpoints. Regarding the primary endpoint, the difference in SpO 2 between the auto-DODS and continuous flow was 0.835%. Since the upper limit of this difference did not exceed 2.8, which was set as the noninferiority margin, it was shown that the auto-DODS did not reduce SpO 2 by at least 2.8% on average compared to continuous flow. No equipment failure or exacerbation of disease was observed, confirming the safety of the auto-DODS during the night.