Runold Michael, Karlsson Ingegerd, Borén Magda
Department of Respiratory Medicine and Allergology, Karolinska University Hospital, Solna, 171 64, Sweden.
Department of Medicine, Karolinska Institute, Stockholm, Sweden.
Respir Res. 2025 May 26;26(1):200. doi: 10.1186/s12931-025-03274-x.
Chronic respiratory insufficiency associated with severe resting hypoxemia necessitates long-term oxygen therapy (LTOT), yet existing devices often impede daily activities due to cumbersome flow adjustments, increasing reliance on caregivers. FlexO2 is a novel mechanical regulator that enables switching between preset oxygen flow rates for rest and activity. This proof-of-concept study evaluated its impact on patient autonomy, physical activity, and quality of life.
In a consecutive, non-randomized pre-post intervention proof-of-concept study at Karolinska University Hospital, 26 patients on LTOT (median age 77; 69% COPD) used FlexO2 for three months. The device, worn around the neck, allowed patients to self-adjust oxygen doses without accessing the concentrator. Outcomes included ease of use measured by visual analogue scale (VAS), physical activity levels, COPD Assessment Test (CAT), EQ-5D-5 L index, and frequency of dose adjustments.
Ease of dose adjustment increased from a VAS score of 14 to 92 (p < 0.001), with 92% of patients reporting improved ease of adjustment (baseline 7.7%; p < 0.001). Daily adjustment frequency doubled (8 to 15; p = 0.001). Patient-reported activity capacity improved from a VAS of 11 to 80 (p < 0.001). Quality-of-life scores measured by VAS increased from 19 to 61 (p < 0.001), while CAT scores decreased from a median of 26.0 to 22.5 (p = 0.05). The EQ-5D-5 L index remained stable (0.68 to 0.70; p = 0.7), although 38% of patients showed individual improvements. Device usability was high (83% satisfaction), though 15% reported tubing tangling or airflow issues.
FlexO2 significantly improved the ease of oxygen dose adjustment and physical activity capacity, potentially enhancing patient autonomy in LTOT. While overall patient-reported quality-of-life scores improved, objective quality-of-life outcomes remained stable. Further studies are warranted to explore long-term clinical outcomes and the potential impact on caregiver burden.
与严重静息性低氧血症相关的慢性呼吸功能不全需要长期氧疗（LTOT），然而现有设备往往因流量调节繁琐而妨碍日常活动，增加了对护理人员的依赖。FlexO2是一种新型机械调节器，可在预设的休息和活动氧流量之间切换。这项概念验证研究评估了其对患者自主性、身体活动和生活质量的影响。
在卡罗林斯卡大学医院进行的一项连续、非随机的干预前后概念验证研究中，26例接受LTOT的患者（中位年龄77岁；69%为慢性阻塞性肺疾病（COPD）患者）使用FlexO2三个月。该设备佩戴在颈部，使患者无需操作制氧机即可自行调节氧气剂量。结果包括通过视觉模拟量表（VAS）测量的易用性、身体活动水平、COPD评估测试（CAT）、EQ-5D-5L指数以及剂量调节频率。
剂量调节的易用性从VAS评分14分提高到92分（p<0.001），92%的患者报告调节易用性有所改善（基线时为7.7%；p<0.001）。每日调节频率翻倍（从8次到15次；p=0.001）。患者报告的活动能力从VAS评分11分提高到80分（p<0.001）。通过VAS测量的生活质量评分从19分提高到61分（p<0.001），而CAT评分从中位数26.0降至22.5（p=0.05）。EQ-5D-5L指数保持稳定（从0.68到0.70；p=0.7），尽管38%的患者有个体改善。设备易用性较高（满意度为83%），不过15%的患者报告有管路缠绕或气流问题。
FlexO2显著提高了氧气剂量调节的易用性和身体活动能力，可能增强了LTOT患者的自主性。虽然患者报告的总体生活质量评分有所改善，但客观生活质量结果保持稳定。有必要进一步研究以探索长期临床结果以及对护理人员负担的潜在影响。
