Nasotracheal Intubation Using Shikani Optical Stylet
Condition: Intubation; Difficult
Study type: Interventional

Summary: 
      Difficult airways is still a challenging issue for the anesthesiologists in spite of the
      development of various techniques.Shikani optical stylet(SOS), combining the features of
      fiberoptic bronchoscope and a lightwand, has been used for orotracheal intubation with
      difficult airways. As compared with fiberoptic bronchoscope, SOS is less expensive, easy to
      learn and more durable. However, it remains elusive whether SOS can be used in the
      nasotracheal intubation in the oral and maxillofacial surgery, which normally requires the
      nasotracheal intubation. The present study evaluates the safety and efficacy of SOS for
      nasotracheal intubation in the oral and maxillofacial surgery requiring nasotracheal
      intubation.
    

Detailed description: 
      The present study has been approved by the Research Ethics Committee of the Second Xiangya
      Hospital of Central South University . Informed and written consent will be obtained from
      patients who are undergoing oral and maxillofacial surgery requiring general anesthesia with
      nasotracheal intubation. Preoperative clinical assessment of the patients will include
      routine airway evaluation of dentition, mouth opening, tongue size, Mallampati score, and
      neck mobility.

      For the patients without anticipated difficult intubations. Patients will be induced by the
      routine anesthesia fashion including 0.1mg/kg midazolam, 3-8mcg/kg fentanyl, 0.08-.015mg/kg
      vecuronium and 0.3mg/kg etomidate with standard preoxygen. The patients will be ventilated
      with 100% oxygen via bag and mask for 3 minutes.

      For the patients with anticipated difficult airways. Patients will be inhaled with
      sevoflurane in 100% oxygen. Some protocols will be performed as the following: 1)If the
      patient can be ventilated with bag and mask after losing consciousness, 0.3mg/kg etomidate
      and 1-2mg/kg succinylcholine will be administered for muscle paralysis. If not, sevoflurane
      will be stopped and the patient will be awakened. Fiberoptic bronchoscope will be performed
      for the intubation; 2)If two attempts of intubation with SOS are failed, then the direct
      laryngoscope will be used for the intubation; If the intubation with direct laryngoscope is
      also failed, the patients will be awakened and intubated in the awake status.

      After confirmation of the successful intubation, the routine anesthesia fashion will be
      followed and the surgery will be performed as the usual fashion.

      Intubation time will be defined as the time from when Shikani stylet passes the nose of the
      patient until the time the endotracheal tube is positioned in the trachea. If the intubation
      sequence is longer than 120 seconds, it will be deemed a failure and recorded as such.
    

Intervention name(s): Nasotracheal Intubation through seeing optical stylet (SOS)
Intervention type(s): Procedure
Intervention description(s): Nasotracheal intubation using seeing optical stylet in the patients with the anticipated difficult intubation. Arm 1:routine anesthesia induction,0.1mg/kg midazolam, 3-8mcg/kg fentanyl, 0.08-0.15mg/kg vecuronium and 0.3mg/kg etomidate, Nasotracheal intubation with seeing optical shikani; Arms 2: Sevoflurane combined with oxyge, 0.3mg/kg Etomidate and 1-2mg/kg succinylcholine for intubation, nasotracheal intubation with seeing optical shikani
Other intervention name(s): fluoroscopy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Shikani optical stylet(SOS); difficult airways; intubation