Impact of self-administered pulse oximetry among non-hospitalized patients at risk of severe COVID-19 in Honduras: A pragmatic, cluster-randomized trial with temporal clustering

TL;DR

A study in Honduras found that using self-administered pulse oximetry for non-hospitalized high-risk COVID-19 patients increased referrals for care but did not reduce hospitalizations.

Contribution

This is the first pragmatic trial in a lower-income country assessing the impact of self-administered pulse oximetry on severe COVID-19 outcomes.

Findings

Self-administered pulse oximetry increased referrals for clinical evaluation among high-risk patients.

There was no significant difference in hospitalization rates between the groups.

The study found low incidence of severe outcomes, making it hard to assess the intervention's impact on mortality or ventilation.

Abstract

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.

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