masimo Rad-G
Pulse Oximetry

Masimo Highly Accurate in Pediatric Respiratory Rate Study

Masimo announced the results of a study published in Pneumonia in which independent researchers in New Delhi, India, investigated the accuracy of Masimo RRp® on pediatric patients with the Rad-G™ Pulse Oximeter by comparing it to clinician-determined values while performing routine assessment of children admitted to outpatient and emergency departments.1 RRp provides respiration rate determined from the photoplethysmograph used in pulse oximetry.

Noting the high incidence of childhood pneumonia in many parts of the world, the inclusion of oxygen saturation (SpO2) and respiratory rate measurement in pneumonia screening guidelines, and the scarcity of medical equipment and variability in medical training in many low-resource settings, Dr. Alwadhi and colleagues sought to determine whether a “multi-modal” pulse oximeter, Masimo Rad-G, could also accurately measure respiration rate—supporting future applications for a more streamlined and reliable approach to pneumonia screening case management. Rad-G uses a single Masimo SET® pulse oximetry sensor to measure both SpO2 and RRp, as well as pulse rate (PR), perfusion index (Pi), and pleth variability index (PVi®).

In this particular study, the researchers used Rad-G, alongside traditional pediatrician assessment, to measure the respiration rate of 97 children (aged 2 to 59 months) admitted to the outpatient and emergency departments at Kalawati Saran Hospital in New Delhi, over 2 weeks. They then analyzed the level of agreement between plethysmography-based respiration rate (RRp) and the clinicians’ assessment of respiration rate.

The researchers found that RRp and the control respiration rate measurement method showed “significant strong association (97%)” (p < 0.001), and that “values obtained either from pulse oximeter or by pediatrician (gold standard) are very close to each other.” For assessing fast breathing (defined as ≥ 50 breaths per minute (bpm) for infants 2 to 12 months and ≥ 40 bpm for children older than 12 months), RRp had high sensitivity (95%) and specificity (94%), with 95% accuracy. Based on these findings, the authors explained, “The sensitivity analysis, in addition, points to the reliability of the device in correctly identifying fast breathing, a major symptom of the disease [pneumonia], in 95% of the cases.” They also noted that Rad-G “allows for significantly integrated results of RR and SpO2 with high sensitivity and accuracy in health care settings, as well as the possibility of rapid detection.”

The researchers concluded, “There is a high degree of agreement between pleth-based RR using a [pulse oximetry device] and physician measured RR, indicating that the former provides reliable and accurate measurement. Current diagnosis and management of pneumonia in primary health care is based on variably trained health providers despite IMCI [Integrated Management for Childhood Illness] guidelines. The use of pulse oximeters, also recommended by the WHO, which can provide reliable measurement, would streamline pneumonia case management in these settings. The current study provides evidence of the reliability of pulse oximeter[s].”

Masimo RRp is CE marked and U.S. FDA 510(k) cleared. Rad-G is currently CE marked and the U.S. FDA 510(k) clearance is pending.

References

  1. Alwadhi V, Sarin E, Kumar P, Saboth P, Khera A, Gupta S, Kumar H. Measuring accuracy of plethysmography based respiratory rate measurement using pulse oximeter at a tertiary hospital in India. Pneumonia. 2020. 12:4. https://doi.org/10.1186/s41479-020-00067-2.
  2. Published clinical studies on pulse oximetry and the benefits of Masimo SET® can be found on our website at http://www.masimo.com. Comparative studies include independent and objective studies which are comprised of abstracts presented at scientific meetings and peer-reviewed journal articles.
  3. Castillo A et al. Prevention of Retinopathy of Prematurity in Preterm Infants through Changes in Clinical Practice and SpO2 Technology. Acta Paediatr. 2011 Feb;100(2):188-92.
  4. de-Wahl Granelli A et al. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009;Jan 8;338.
  5. Taenzer AH et al. Impact of pulse oximetry surveillance on rescue events and intensive care unit transfers: a before-and-after concurrence study. Anesthesiology. 2010:112(2):282-287.
  6. Taenzer A et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
  7. McGrath SP et al. Surveillance Monitoring Management for General Care Units: Strategy, Design, and Implementation. The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302.Estimate:
  8. Masimo data on file.
  9. http://health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview.

Source: Masimo

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