Monitoring calls and warning signs and symptoms.

The World Health Organization recommends remote monitoring and self-administered pulse oximetry to identify silent hypoxia and the need for medical intervention in non-hospitalized high-risk COVID-19 patients. These interventions have been evaluated previously, but evidence is needed to determine the impact on morbidity and mortality, particularly in lower- and middle-income countries. A prospective, pragmatic, open-label trial was conducted in Tegucigalpa and Comayagüela, Honduras to evaluate the impact of self-administered pulse oximetry to reduce morbidity and mortality among non-hospitalized patients at high risk of adverse COVID-19 outcomes enrolled in a remote monitoring program. Participants were cluster-randomized, with temporal clustering by day, to remote monitoring plus self-administered pulse oximetry versus remote monitoring alone. Participants received daily calls to assess for high-risk clinical features, including hypoxia (SpO2 ≤ 94%) in the pulse oximetry arm. All participants reporting high risk symptoms were referred for in-person evaluation. ClinicalTrials.gov, ID number NCT04886414. Between March 30, 2022 and January 24, 2023, 1,821 participants met the intention to treat analysis criteria; 925 were randomized to remote monitoring and 897 to remote monitoring with pulse oximetry. Nearly 99% of participants reported receiving one or more COVID-19 vaccine doses, and 90.2% three or more doses, with similar coverage across arms. Pulse oximetry arm participants were more likely to be referred for clinical evaluation (OR 1.60 [95% CI 1.09 – 2.46], p = 0.018), but not more likely to be hospitalized (OR 1.55 [95% CI 0.55 – 4.37, p = 0.401]. One participant died, two required intensive care, and none required ventilation. Findings suggest that self-administered pulse oximetry increased referral for additional care but did not influence hospitalization rates among a high-risk, highly vaccinated, population with low incidence of severe COVID-19. Given infrequent progression to severe COVID-19, the relationship between the intervention and mortality, mechanical ventilation, or admission to intensive care was not assessed.世界卫生组织 (World Health Organization) 推荐对非住院的高危新型冠状病毒肺炎 (COVID-19) 患者采用远程监测与自行指脉血氧监测 (pulse oximetry)，以识别静默缺氧及医疗干预需求。此前已针对此类干预措施开展过评估，但仍需相关证据明确其对发病率与死亡率的影响，尤其在中低收入国家。本研究在洪都拉斯的特古西加尔巴与科马亚瓜开展了一项前瞻性、实用性、开放标签临床试验，旨在评估自行指脉血氧监测在远程监测项目中，对降低不良新冠预后高危非住院患者的发病率与死亡率的作用。研究对象按每日时间集群进行整群随机分组，分为远程监测联合自行指脉血氧监测组与单纯远程监测组。所有受试者每日都会接到电话，以评估是否存在高危临床特征，指脉血氧监测组受试者需监测血氧饱和度 (SpO2 ≤94% 即为缺氧)。所有报告存在高危症状的受试者均会被转诊至线下评估。本试验在 ClinicalTrials.gov 的注册编号为 NCT04886414。2022年3月30日至2023年1月24日期间，共有1821名受试者符合意向治疗分析 (intention to treat analysis) 标准；其中925名被随机分至单纯远程监测组，897名被分至远程监测联合指脉血氧监测组。近99%的受试者报告已接种至少1剂新冠疫苗，90.2%的受试者接种了3剂及以上疫苗，两组的疫苗接种覆盖率无显著差异。指脉血氧监测组受试者更有可能被转诊至临床评估 (比值比 OR=1.60，95% 置信区间 CI：1.09~2.46，P=0.018)，但住院率无显著升高 (OR=1.55，95%CI：0.55~4.37，P=0.401)。本次研究中仅1名受试者死亡，2名需重症监护，无受试者需机械通气。研究结果表明，在高危且高疫苗接种率、重症新冠发病率较低的人群中，自行指脉血氧监测可增加额外诊疗的转诊率，但未对住院率产生影响。由于重症新冠进展事件较为罕见，本研究未评估该干预措施与死亡率、机械通气或重症监护病房收治之间的关联。