Randomized, Active-Controlled, Parallel-Group Clinical Study Assessing the Efficacy and Safety of FKScope(R) for Nasotracheal Intubation in Patients Scheduled for Oral and Maxillofacial Surgery Under General Anesthesia.

BACKGROUND: Most of the reports showed that videolaryngoscopy has better outcomes than direct laryngoscopy for nasotracheal intubation. The FKScope(R) comprises a semirigid and malleable stylet with a terminal camera and has been used to facilitate orotracheal intubation. However, its efficacy and safety for nasotracheal intubation remain unknown. This study compared FKScope(R) with Macintosh direct laryngoscopy for nasotracheal intubation. METHODS: Sixty-four patients scheduled for oral and maxillofacial surgery requiring nasotracheal intubation were enrolled and randomly assigned to FKScope(R) (n = 32) or Macintosh group (n = 32). The primary outcome was time to successful intubation during the first attempt. Secondary outcomes included modified nasal intubation difficulty scale (MNIDS) scores; percentage of glottic opening (POGO); immediate postintubation side effects such as mucosal bleeding, dental injury, and lip lacerations; and postoperative side effects including nasal pain, sore throat, hoarseness, dysphagia, and dyspnea. RESULTS: The rates of successful first-attempt intubation were 87.5% and 90.6% in the FKScope(R) and Macintosh group, respectively (P = 0.69). Mean (+/- standard deviation) total intubation time was 68.7 +/- 34.8 s in the FKScope(R) group compared with 61.5 +/- 21.9 s in the Macintosh group (P = 0.35), despite a higher POGO for the FKScope(R) group (77 +/- 27 vs. 41 +/- 31, P ＜ 0.01). The MNIDS scores of the FKScope(R) group were significantly lower (0.8 +/- 1.0 vs. 2.8 +/- 1.4, P ＜ 0.01). The groups did not differ significantly regarding most postoperative side effects, although the FKScope(R) group had fewer lip lacerations (P = 0.04). CONCLUSIONS: The use of FKScope(R) improves the view of the glottic opening and is safe for nasotracheal intubation with normal airways. However, secretions and blood can obstruct the camera, and therefore, to select the patient carefully is necessary.