Clinical trial NCT03097913: Technique Using Trachway to Safely Navigate Endotracheal Tube Through Nasal Cavity
Official title: Kaohsiung Medical University Chung-Ho Memorial Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nasotracheal Intubation
Keywords: nasotracheal intubation
video-stylet
nasal cavity injury
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
First posted: 2017-03-31
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients undergoing regular oro-maxillofacial surgery are included in the study from a medical university hospital (medical center)

Brief summary: To investigate the double curve endotracheal tube safely navigate through nasal cavity under guidance of a video-stylet.

Detailed description: we enrolled consecutive patients undergoing oxo-maxillofacial surgery by using video-stylet to establish airway and realize the tube angle changes while advancement, however, patients who did not inform or refuse to enroll into the study still use the video-stylet establish airway. the technique to use videostylet-tube assembly to establish airway is a commonly clinical practice in our hospital.

In general, the endotracheal tube goes through nasal cavity blindly either assist with traditional laryngoscope or video-laryngoscope. Tube advances through selected nasal cavity by using a video-stylet is able to prevent from damages of the abnormal turbinates and tissue mucosa. In addition, we are able to record the stylet angle into nostril, shift axis angle in nasal cavity to prevent orifice and side hole from damaging tissues while tube-stylet assembly advancement, and the angle ranges from initiate intubation to tube advanced into trachea.

the selected nostril is determined by Otolaryngologist who is not aware of the study.

Eligibility criteria: Inclusion Criteria:

* patients undergo regular operation of oro-maxillofacial surgery

Exclusion Criteria:

* easily nasal bleeding, mouth limited (opening mouth \< 3cm), hypertension, diabetes, chronic sinusitis with operative history, patients unwilling to be included.

Primary outcomes:
measure: assessment nasal cavity and nasopharyngeal tissues damages
timeFrame: 5-10 minutes
Secondary outcomes:
measure: video-stylet forward trend and angle changes during intubation
timeFrame: 5-10 minutes
measure: postoperative nasal damages
timeFrame: 24 hours
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Department of Anesthesiology, Kaohsiung Medical University Chung-Ho Memorial Hospital
Study officials:
affiliation: Kaohsiung Medical University Chung-Ho Memorial Hospital
name: kuang I Cheng, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Hsu HT, Lin CH, Tseng KY, Shen YC, Chen CH, Chuang WM, Cheng KI. Trachway in assistance of nasotracheal intubation with a preformed nasotracheal tube in patients undergoing oral maxillofacial surgery. Br J Anaesth. 2014 Oct;113(4):720-1. doi: 10.1093/bja/aeu334. No abstract available.
citation: Lee MC, Tseng KY, Shen YC, Lin CH, Hsu CW, Hsu HJ, Lu IC, Cheng KI. Nasotracheal intubation in patients with limited mouth opening: a comparison between fibreoptic intubation and the Trachway(R). Anaesthesia. 2016 Jan;71(1):31-8. doi: 10.1111/anae.13232. Epub 2015 Oct 12.