SBIR Phase I: A Medical Device to Secure Endotracheal Tubes and Reduce Unplanned Extubations for Neonates in Intensive Care

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project is to develop a device that effectively and reliably secures endotracheal tubes for babies in the neonatal intensive care unit. Endotracheal tubes are airways placed in patients to help them breathe, but babies in the NICU experience high rates of unplanned dislodgement and early removal. These dangerous events are primarily attributed to poor and ineffective securement of the endotracheal tube to the patient. An integrated solution to endotracheal tube securement would reduce complications for the 80,000+ neonatal intubations that occur every year in the United States. This is especially urgent in lower-resourced settings that may have limited staff that are experienced in neonatal resuscitation. This project will develop a new system to support these patients. This Small Business Innovation Research (SBIR) Phase I project enables advanced patient securement to minimize the risk of unplanned extubations. Endotracheal tube securement presents unique challenges in neonates, given their delicate and small anatomy. The research objectives include developing a custom adhesive that maintains functionality in incubator environments and in use on underdeveloped neonatal facial skin; designing, validating, and manufacturing device securement mechanisms; and conducting bench testing and simulated use testing with clinicians. This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.