This Phase 1 SBIR proposal focuses on increasing ventilation safety for patients as they recover from surgery in the hospital while also reducing the work burden for clinicians. The underlying cause in 2 of every 3 unexpected hospital deaths is hypoventilation, a condition in which patients do not breathe enough. After surgery, many patients receive medication to control pain which can severely reduce their drive to breathe. The patient deaths that follow are clearly preventable if hypoventilation is detected early and the patient is awakened and prompted to breathe. In this project, we will build on a promising preliminary study to further develop an automated system that interacts directly with the patient to prompt them to breathe and is intuitive for clinicians to use. We plan to place a small wireless motion sensor and a low- cost pulse oximeter on the finger and a respiration monitor on the nose. When these sensors detect hypoventilation and very little hand motion with low oxygen saturation, the automated system will use a speaker by the bedside to wake the patient and directly verbally prompt them by name to breathe. If the patient does not respond, the system will immediately notify the nurse that help is needed. A display of breath prompting, breath rate and oxygen saturation history will help clinicians decide whether medication doses should be adjusted to prevent further hypoventilation. This proposal will allow advancement of the hardware, algorithm and user interface used in preliminary work as well as conduct a human clinical study to assess effectiveness and reduction in nurse workload. In Phase II, the device will be refined and tested in patients on the general floor. Axon's team has demonstrated commercial success with several devices and looks forward to bringing this device through FDA 510(k) to commercialization and preventing unexpected hospital deaths from hypoventilation.
Public Health Relevance Statement: PROJECT NARRATIVE The majority of unexpected hospital deaths in the US can be attributed to too little breathing (hypoventilation), a condition that frequently occurs when patients receive pain medication following surgery. The medication often reduces patients' ability to sustain proper breathing and oxygen levels and current monitoring for hypoventilation is grossly inadequate. We propose a robust but simple monitoring system that will detect this situation and automatically rescue these patients by prompting them by name to take a deep breath. The system keeps the patient safe and helps clinicians know when to adjust the pain medication.
Project Terms: Address; Adverse effects; Algorithms; Analgesics; Arousal; Awareness; Axon; base; Breathing; Capnography; Cardiac; Cessation of life; Clinical; Clinical Data; Clinical Research; commercialization; computerized data processing; Conscious; cost; Data Analyses; Data Collection; design; Devices; Documentation; Dose; Effectiveness; Environmental air flow; Event; experience; Failure; Fingers; Floor; forgetting; General Hospitals; General Ward; Hand; Heart Rate; Hospitals; Hour; Human; Hypercapnic respiratory failure; improved; innovation; Learning; Methodology; Monitor; Motion; Names; Nose; Nurses; Operative Surgical Procedures; Oxygen; Pain; Pain management; Patient Monitoring; patient safety; Patients; Pharmaceutical Preparations; Phase; Physiologic pulse; Postoperative Period; prevent; Recording of previous events; Resources; Respiration; respiratory; Running; Safety; Sensitivity and Specificity; sensor; Signal Transduction; Small Business Innovation Research Grant; Spottings; standard of care; success; System; Tablets; Testing; Time; touchscreen; Update; ward; Wireless Technology; Work; Workload
