Technique Using Trachway to Safely Navigate Endotracheal Tube Through Nasal Cavity

NCT03097913 — Completed, 100 participants, Kaohsiung Medical University Chung-Ho Memorial Hospital

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Kaohsiung Medical University Chung-Ho Memorial Hospital

Registry	NCT03097913, acronym video-stylet
Status	Completed
Study type	Observational
Enrollment	100 (Actual)
Sponsor	Kaohsiung Medical University Chung-Ho Memorial Hospital (Other)
Conditions	Nasotracheal Intubation
Interventions	video-stylet (Device)
Dates	start 2017-04-05, primary completion 2019-08-08, completion 2019-08-31, first posted 2017-03-31, last updated 2024-06-21
Locations	1 site in Taiwan

-Summary

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

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
video-stylet tube assembly		Device: video-stylet	patients who undergo oxo-maxillofacial surgery with nasotracheal intubation general anesthesia are recruited

video-stylet (Device): recording each video-stylet endotracheal tube assembly advanced through the selected nasal cavity

+Outcome measures

Primary outcomes

assessment nasal cavity and nasopharyngeal tissues damages [5-10 minutes]: using video-stylet to safely navigate through selected nasal cavity and advancement into trachea

Secondary outcomes

video-stylet forward trend and angle changes during intubation [5-10 minutes]: put tube-stylet assembly into selected nostril needs change the vectors while advancement
postoperative nasal damages [24 hours]: measurement of nasal bleeding and nasal congestion and nasal pain

+Eligibility

Sex: All, ages: 20 Years to 65 Years

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.

+Locations (1)

Facility	City	Country	Status
Department of Anesthesiology, Kaohsiung Medical University Chung-Ho Memorial Hospital	Kaohsiung City	Taiwan

+Publications

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. PMID 25236899
Results publication: 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. PMID 26460721

+Investigators

kuang I Cheng, MD, PhD, Study director, Kaohsiung Medical University Chung-Ho Memorial Hospital