Development of an Improved LASER-Resistant Endotracheal Tube.

Abstract

Surgical fires, particularly within Otolaryngology, remain a surprisingly frequent and devastating complication of laser-related surgery in the oropharynx and airway; Current estimates suggest anywhere from 200 to 600 surgical fires per year in the United States, with 20%-30% of these occurring as a complication of laser surgery and 90%-95% of these occurring in the head and neck region. Unfortunately, the complications of laser surgery in the airway may include respiratory failure, airway burns with stenosis, and may result in mortality. The most commonly utilized endotracheal tube for protection against inadvertent laser strikes, the Laser-Shield II tube (Medtronic), was removed from the commercial marketplace in 2016 after cases of airway fires were reported as a result of feature deficiencies in the product (FDA MAUDE Database review). Since the demise of the Laser-Shield II tube, alternatives such as the Mallinckrodt laser tube and handmade reinforced tubes have been utilized, although shortcomings in design and features have made these options less appealing to practicing Otolaryngologists. Creating a laser-safe endotracheal tube is critical for safe upper airway surgery. This paper evaluates new technologies, materials, and technical innovations in endotracheal tubes that may advance patient safety in laser-assisted Otolaryngology procedures. This paper evaluates new technologies, materials, and technical innovations in endotracheal tubes that may advance patient safety in laser-assisted Otolaryngology procedures. First, this article reviews the background of laser surgery in Otolaryngology and the consequent risk of surgical fire with resultant development of laser-resistant endotracheal tubes and commercial availability. Next, a review of claims and national database review of product failures related to previous laser-resistant endotracheal tubes is performed through the FDA MAUDE database. This includes an evaluation of cases: review of techniques in laser airway surgery including spontaneous ventilation, decreased O2 concentration, currently available endotracheal tubes including "handmade" fixes for perceived safety risks, and determination of failure points for previous laser-resistant endotracheal tubes. Third, the paper reviews the requested features of an "ideal" laser-resistant endotracheal tube. Finally, the paper reviews failure testing from an initial, unsuccessful attempt at material development and the consequent development of alternative technologies that address failure points from previous endotracheal tubes and addresses requested features with a detailed analysis of FDA-approval required testing. Extensive lab testing of the new tube predicts a significant reduction of risk in vivo with inability to perforate the shaft or cuff of the tubes under standard working conditions. While no iteration of a laser-resistant endotracheal tube is entirely laser safe, advances in technology can improve the safety profile of these devices. The new tube contains a double cuff, a soft and flexible shaft to minimize laryngeal insertion trauma, a smooth external surface, a tight-to-shaft balloon, and methylene blue dye in the cuff to alert the user to inadvertent penetration. These characteristics were the most requested by laryngologists in the development of a new laser-resistant tube. The newest endotracheal tube brings the features most requested by Otolaryngologists in a laser-resistant tube, and improves the safety profile over previous tubes. Development of a new endotracheal tube represents an advancement in safety for the Otolaryngologist in laser airway surgery. Understanding the previous history and the science behind surgical fire formation is essential in advancing safety for patients in the future. N/A Laryngoscope, 134:S1-S12, 2024.