Technique Using Trachway to Safely Navigate Endotracheal Tube Through Nasal Cavity

Nasotracheal Intubation Clinical Trial

— video-stylet  

Official title:

Kaohsiung Medical University Chung-Ho Memorial Hospital

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03097913
• Other study ID #: KMUHIRB-E(II)_20160112
• Status: Completed
• Start date: April 5, 2017
• Est. completion date: August 31, 2019

Study information

• Verified date: March 2017
• Source: Kaohsiung Medical University Chung-Ho Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 31, 2019
• Est. primary completion date: August 8, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Nasotracheal Intubation

Intervention

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

Locations

Country	Name	City	State
Taiwan	Department of Anesthesiology, Kaohsiung Medical University Chung-Ho Memorial Hospital	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
Kaohsiung Medical University Chung-Ho Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	assessment nasal cavity and nasopharyngeal tissues damages	using video-stylet to safely navigate through selected nasal cavity and advancement into trachea	5-10 minutes
Secondary	video-stylet forward trend and angle changes during intubation	put tube-stylet assembly into selected nostril needs change the vectors while advancement	5-10 minutes
Secondary	postoperative nasal damages	measurement of nasal bleeding and nasal congestion and nasal pain	24 hours