Masimo Rad-G Helps Clinicians Identify Pediatric Pneumonia In Large Field Trial In India

Masimo announced the findings of a study published in Clinical Medicine Insights: Pediatrics in which Dr. Harish Kumar and colleagues at IPE Global in New Delhi, India reported on their experience using the Masimo Rad-G Pulse Oximeter to aid health providers in pneumonia case detection and management in more than 4,500 children under five years who presented with symptoms of acute respiratory infection (ARI). Rad-G is a rugged, portable, handheld Masimo SET Measure-through Motion and Low Perfusion pulse oximeter and noninvasive respiration rate monitor from the pleth (RRp). The researchers found that Rad-G was “highly acceptable among health workers” and aided the “timely classification and treatment” of pneumonia—helping them achieve correct case management in more than 91% of cases of ARI and reduce the unnecessary use of antibiotics.

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Study author Dr. Kumar commented, “Our decision to choose Rad-G as our pulse oximeter of choice to aid HWCs in pneumonia screening proved to be a good one. The device is easy to use and maintain, even in low-resource settings, and because of its ability to accurately and reliably measure SpO₂ and RR, it has the potential to transform the identification and management of pneumonia by healthcare workers, even those who may not be medical doctors. We hope that our study will help convince many more Indian states of the value of integrating use of Rad-G and its technological benefits into their care practices, supporting nationwide efforts to successfully diagnose and treat as many cases of pediatric pneumonia as possible.”

As the authors note, pneumonia – one of the most common causes of ARI in children – contributes to 15% of child deaths across the world, with India accounting for 20% of those deaths. In low-resource health settings, where access to diagnostic aids is limited, health workers often rely on manual counts of respiratory rate to inform ARI management decisions. In this trial, researchers evaluated oxygen saturation (SpO₂) and respiratory rate (in accordance with WHO guidelines for effective pneumonia management) measured by Rad-G. Given the often “inadequate skills” of front-line healthcare workers in low-resource and rural settings—for example, it was found that the majority of workers at Indian Health and Wellness Centers (HWCs) “lacked knowledge on how to correctly assess a child with cough or difficult breathing”—the authors hoped that Rad-G could help workers more readily diagnose pneumonia, prove to offer good “usability,” and ultimately, contribute to India’s goal of aggressively reducing child deaths due to pneumonia.

The researchers chose Rad-G from among other available pulse oximeters for a variety of reasons, in particular its integration of respiration rate from the pleth (RRp) and accurate and reliable SpO₂. Before proceeding with this larger trial, an initial study at a single tertiary care hospital was conducted in 2019 to evaluate the accuracy of RRp on Rad-G. That study found a 97% association between Rad-G RRp and pediatrician-measured RR, with high sensitivity, specificity, and accuracy.² The authors also noted Rad-G’s long-lasting, rechargeable battery, its LCD display, and the fact that a single sensor could be used on all children under five years. Following the initial study, Rad-G was introduced at 19 HWCs across seven states in India, and its implementation and utility (including usability and durability) were tracked over 15 months, from June 2019 to August 2020. Over this period, a total of 4,846 children aged 2 – 60 months with symptoms of ARI visited the facilities. To aid in assessing cases, providers were given abridged training in India’s Integrated Management of Neonatal and Childhood Illnesses (IMNCI) program, which classifies children with ARI as having severe pneumonia (SpO₂ < 90% or presence of “general danger signs”), pneumonia (fast breathing or chest in-drawing), or neither (none of the above).

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Of the 4,846 children, 0.1% were diagnosed with severe pneumonia and 23% with pneumonia. Reviewing cases on a monthly basis, the researchers found that 91.4% of all cases were correctly managed. In addition, 12 children with severe pneumonia, who were referred, would have been missed without the use of Rad-G pulse oximetry.

The researchers concluded, “The pulse oximeter implementation was found to integrate well within a primary healthcare level. The robustness and ease of usability of the device is perhaps the biggest advantage observed, which has led to some of the states budgeting for PO [pulse oximetry] for scale-up in all the districts. A rigorous evaluation in scaled up facilities should be considered by the government. The implementation tentatively demonstrates that a systematic approach to diagnosing pneumonia is likely to improve case management.”

The authors also noted, “Considering the importance of hypoxemia and fast breathing as a sign of severe illness, an ideal pulse oximeter is one which functions as a point-of-care device, is durable, affordable, easy to maintain and can deliver rapid, reliable noninvasive SpO₂ measurements. A device that measures respiratory rate should also be considered for wider usage given the difficulty among healthcare workers [of] measur[ing] respiratory rate manually. Improving case management of pneumonia at the primary care level by expanding ARI diagnostic aids, while also increasing coverage of IMNCI, strengthening referral pathways, and improving quality of care in referral facilities, will contribute majorly to the SDG [Sustainable Development Goal] goal of reducing under-5 mortality.”

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