731 - A Novel Continuous Respiratory Rate Monitor Intended for Low and Middle Income Countries: A Device Pilot Study.

Publication Number: 731.3909

Amee A. Amin, Division of Neonatology, Dept. of Pediatrics, Baylor College of Medicine/Texas Children's Hospital, Houston, TX, United States; Joshua Coyle, Rice360 Institute for Global Health Technologies, Portland, ME, United States; Rowland Mjumira, Kamuzu University of Health Sciences, Blantyre, Blantyre, Malawi; Lucky Mangwiro, NEST 360 Project, Kamuzu University of Health Sciences, Blantye, Blantyre, Malawi; Maria Oden, Rice University, Houston, TX, United States; Rebecca Richards-Kortum, Rice University, Houston, TX, United States; Queen Dube, Kamuzu College of Health Sciences, Mies, Vaud, Switzerland; Kondwani Kawaza, Kamuzu University of Health Sciences, Blantyre, Blantyre, Malawi; Monika Patil, Baylor College of Medicine, Houston, TX, United States; Prince J. Mtenthaonga, Kamuzu University of Health Sciences, Blantyre, Blantyre, Malawi

Background: Neonatal deaths account for 50% of all under age 5 mortality, and over 80% of the annual neonatal deaths in the world occur in Low– and Middle-income countries (LMIC), largely from preventable causes. Continuous respiratory rate (RR) monitoring in high-income countries (HIC) allows for rapid detection and treatment of serious and life-threatening complications in premature and sick newborns such as respiratory distress syndrome, sepsis, apnea, and seizures. Early detection and treatment of these conditions is pivotal in reducing neonatal mortality and morbidity in HIC. Continuous RR monitors are not widely available in LMIC; thus, the World Health Organization recommends manual breath counting for 60 seconds to measure neonatal RR as the standard of care. However, manual RR monitoring is largely impractical due to high patient-to-nurse ratios in LMIC.

Objective: To address this need for a continuous respiratory rate monitor, a collaborative partnership of clinicians and engineers developed a novel device that identifies breaths by measuring the displacement of an inertial measurement unit sensor placed around a neonate’s abdomen. In this pilot study, we aim to compare the novel device’s performance against reference visual counting.

Design/Methods: We enrolled neonates in a level 3 Neonatal Intensive Care Unit (NICU) in Houston, USA, and level 2 NICU in Blantyre, Malawi to receive continuous monitoring with the novel device. Webcam video monitoring (C925-E, Logitech) was used for manual breath counting. Institutional review board approvals were obtained from all participating institutes.

Results: 20 neonates at the HIC NICU averaging 31.9 weeks [28.4-36.1] and an enrollment weight of 1459g [1035-1975g] were monitored for 40 hours. 4 neonates at the LMIC NICU averaging 31.25 weeks [30 – 33] and an enrollment weight of 1420g [1300-1555] were monitored for 15 hours. Analysis of manual breath counting from 90 selected epochs (each 60 seconds long) indicates that our novel device and reference manual counting show a very strong correlation (R = 0.97). RR mean bias (-0.35) was within the limits of agreement (LOA) for UNICEF target product profile specifications for device validation. No adverse events have occurred. Analysis is ongoing for the remaining 150 epochs.

Conclusion(s): This novel device shows a high degree of accuracy in detecting breaths as compared to the gold standard methods in LMIC. It may offer a low-cost alternative to improve neonatal respiratory monitoring in LMIC, thereby potentially decreasing both the workload burden on nurses and the morbidity and mortality in sick and preterm neonates.

Continuous Monitoring Data and Motion Analysis from Novel Respiratory Rate monitoring Device.
Continuous Monitoring Data and Motion Analysis from Novel Respiratory Rate monitoring Device.

Visual comparison of respiratory rate obtained by novel continuous monitoring device and manual breath counting.
Visual comparison of respiratory rate obtained by novel continuous monitoring device and manual breath counting.

Correlation between respiratory rate obtained by Novel Device and Manual Breath Counting
Correlation between respiratory rate obtained by Novel Device and Manual Breath Counting