With about 50 million surgeries performed annually in the US. Opioids are commonly used as primary analgesicsto control severe surgical pain. However, opioids are associated with several adverse effects including nausea,vomiting, sedation, and more serious respiratory depression and death. Respiratory depression is recognizedas one of the most serious, life threatening and costly complications from perioperative opioids. Althoughpreventable in patients undergoing surgery with effective and early predictions, opioid-induced respiratorydepression continues to be a major contributor to increased morbidity, mortality, length of hospital stay, cost ofhealthcare and malpractice claims. The cost associated with postoperative opioid-induced respiratorydepression in the US is over $650 million annually and $231 million for children alone. While adults withrespiratory and cardiovascular concerns are at high risk of respiratory depression, children are particularlyvulnerable. Over 60% of children undergoing tonsillectomy - the most common surgical procedure in children -are likely to experience adverse post-operative effects including respiratory depression. Current approaches relyon reactive and delayed identification of respiratory depression using costly monitoring and extended hospitalstay for patients. Currently, there is no effective tool to proactively and reliably identify patients at high risk ofopioid-induced postoperative respiratory depression. To address this urgent and unmet need, NeurOptics isdeveloping a first-in-class pupillometry-based tool to proactively predict postoperative respiratory depression inchildren. This technology is based on the patented pupillometry-based respiratory depression prediction modeldeveloped by Dr. Sadhasivam through his NIH-funded clinical research. NeurOptics and Dr. Sadhasivam aim tobring this technology to wide clinical use through this accelerated SBIR Fast-Track proposal. In Phase I,NeurOptics will complete the development of a fully functional prototype, the A-100 device and Intelligent PatientInterface (IPI), as proof-of-concept. Additionally, during this phase, NeurOptics will engage with the FDA forfeedback on the regulatory pathway including the first-of-kind, breakthrough device designation for the A-100.In Phase II, NeurOptics will manufacture beta units of the device and patient interface. These will be verified andused to validate the proposed technology through a clinical study with children undergoing tonsillectomyconducted in collaboration with Dr. Sadhasivam. The perioperative use of this technology will help clinicians toprevent respiratory depression, improve safety of opioids while allowing hospitals to optimize resources. Basedon the current opioid-epidemic related public health crisis and socio-economic burden of opioids (>$500billion/year), a significant commercial market exists for NeurOptics to proactively identify and effectively reduceopioid-related adverse effects including respiratory depression and overdoses in millions of Americans eachyear.
Public Health Relevance Statement: PROJECT NARRATIVE
Opioid-induced respiratory depression is a life-threatening concern that is preventable in patients undergoing
surgery yet continues to be a major contributor to costly morbidity, mortality, length of hospital stay, and
malpractice claims. NeurOptics is developing a pupillometry-based easy to use, bedside tool to predict
postoperative respiratory depression in children in real-time. The perioperative use of this innovative and
impactful technology will help clinicians to prevent respiratory depression, improve safety surgical pain
management with opioids while reducing perioperative cost of care with optimal hospital resource utilization.
Project Terms: <21+ years old><0-11 years old>
