A prospective multicenter trial testing the SCOTI device for confirmation of endotracheal tube placement.

We sought to characterize the Sonomatic Confirmation of Tracheal Intubation (SCOTI) device's ability to confirm endotracheal tube location during real-time intubation in emergency and elective settings. Data were prospectively collected during a multicenter convenience-sample observational trial of emergency and elective intubation cases. In addition to tracheal and inadvertent esophageal intubations in emergency patients, intentional esophageal intubations were also performed to improve specificity calculations in consenting elective surgical patients. Data analysis included descriptive statistics as well as calculations of sensitivity, specificity, and 95% confidence intervals (CI). Data were obtained from 220 tracheal and 103 esophageal intubations, 137 (42%) performed in emergency patients. Fifteen tracheal intubations were incorrectly identified by SCOTI as esophageal and two esophageal intubations incorrectly as tracheal. Sensitivity and specificity were thus 93% (CI 90-97%) and 98% (CI 94-99%), respectively. The two false-positive cases were attributed to gaseous distension of the stomach and esophagus from prolonged bag-valve-mask ventilation. In addition to use in postprocedure tube placement confirmation, SCOTI aided the intubation procedure itself in 45 difficult emergency attempts (33%), 26 of which necessitated blind tube passage. We conclude that the SCOTI device has high sensitivity and specificity for tube placement confirmation during tracheal intubation attempts in both emergency and elective settings. It also facilitates tube placement itself during difficult intubations. As such it may be considered an adjunctive device to minimize the potentially fatal complication of esophageal intubation.