IVOS Medical: Intubation, Optimized.

Abstract Endotracheal intubation is a critical, life-saving procedure, and every second counts. While the process of endotracheal intubation is common, it is still considered a high-risk procedure performed globally. In the US alone, there are 15M operating room intubations and over 1.5M critically ill adults intubated in settings outside of an operating room each year. Failure to intubate the trachea (wind pipe) on the first attempt occurs in 20 to 30% of tracheal intubations performed in the emergency department (ED) or intensive care unit (ICU) and is associated with an increased risk of life-threatening complications. Introduced in the early 2000s, video laryngoscopy was developed to assist with difficult intubation, as an alternative to the traditional practice of direct laryngoscopy. The video laryngoscope functions by means of a video camera situated at the distal end of the laryngoscope blade. This blade is inserted into a disposable plastic `sleeve' to prevent cross-contamination of bodily fluids and promote camera cleanliness during the endotracheal intubation procedure. When inserted into the mouth, it provides an indirect view of the vocal cords on a separate monitor. This tool, widely utilized for airway visualization, has gained increasing acceptance as a first-line intervention for intubation in emergency scenarios. The current problem with video laryngoscopy, like any camera lens, is that the visual field can become obscured when bodily fluids or solids adhere to its external surface. This issue is among the most common causes for failed intubation in pre-hospital, EDs, and ICU settings. During an intubation procedure, the operator must suction away bodily fluids with a separate suction catheter and often physically remove the scope from the mouth to wipe the external camera lens clean. This occurs while the patient is not breathing and potentially becoming increasingly hypoxic. Research indicates that the failure rate escalates to 60-75% by the third intubation attempt, underscoring the critical importance of securing the breathing tube on the first attempt. IVOS Medical is a device company developing an improved video laryngoscope sleeve named the Breathing Optimization and Suction System (BOSS) G4. The BOSS G4 is a single-use, one-piece, sleeve, designed to fit over existing video laryngoscope camera systems. When tested on our controlled vomiting manikin among 54 airway specialists, the BOSS G4 demonstrated statistically faster intubation by securing the airway 12 seconds quicker, reduction in measured pulmonary aspiration by 37 mL, and achieving a first-pass success rate of 98%. The goal of this Phase II research proposal is to continue Phase I development and manufacture clinical-ready units under Good Manufacturing Practice, conduct a preclinical study using human cadavers, and conclude with an in-human feasibility trial at the University of California, Irvine Medical Center. Successful completion of this NIH SBIR Phase II, will lead to a commercial ready process for manufacturing clinical-ready BOSS G4 units, for wide spread use. We anticipate that the positive health and economic outcomes resulting from our efforts will benefit patients, hospitals, and our company alike.