Work

Clinical Evaluation of Pediatric Pulse Oximeters in South Africa: Protocol for a Cluster Randomized Controlled Trial

Year: 2026

Type: article

Abstract: BACKGROUND: The burden of children with lower respiratory infections and low blood oxygen levels (hypoxemia) is high and outcomes are poor in low-and-middle-income countries (LMICs). Pulse oximeters non-invasively measure the capillary oxyhemoglobin saturation (SpO2) to identify hypoxemia, but high-quality devices designed for the unique needs of children are rarely available in primary healthcare clinics (PHCs) in LMICs where children initially access care. OBJECTIVE: To evaluate whether two pediatric pulse oximeters co-designed with healthcare workers (HCWs) in LMICs, compared to a standard pulse oximeter, improve the correct SpO2 management of children in PHCs. METHODS: We are conducting a pragmatic three-arm cluster randomized controlled trial in the Eastern Khayelitsha, Northern, and Tygerberg areas of Cape Town, South Africa, over 18 months between 2024-2026. We plan to enroll 1,200 <2-year-olds with an acute respiratory infection from 18 PHCs randomized to implement one of three pulse oximeters, either one standard of care device or two intervention devices. HCWs in selected PHCs will administer the intervention. Our primary outcome will be 'correct SpO2 management,' an intermediate clinical endpoint between device implementation and hypoxemia outcome, and is defined by the three elements necessary to reduce inappropriately treated hypoxemia, (1) device adoption: HCW use of the device as evidenced by a HCW documented SpO2 and pulse rate, (2) quality SpO2 measurement: SpO2 confirmed by reference device measurement within 2% SpO2 above or below the HCW SpO2, and (3) correct SpO2 decision-making: an appropriate referral recommendation by the HCW. A concurrent mixed methods process evaluation will explore how, why, for whom, and to what extent these devices impact the clinical management of hypoxemic children. The primary analysis will be intention to treat, and for all primary and secondary outcomes, we will conduct pairwise comparisons between the two intervention arms and the control arm. RESULTS: Data collection commenced in 2024. Results are expected in 2026-2027. CONCLUSIONS: While there are notable challenges inherent to designing a trial to evaluate whether pulse oximeters improve HCW SpO2 management of children at PHCs, our protocol development process attempted to address all potential limitations and sources of bias to maximize the trial's future impact. CLINICALTRIAL: Clinicaltrials.gov (NCT05914324).

Source: JMIR Research Protocols

DOI: 10.2196/82888