Technique Using Trachway to Safely Navigate Endotracheal Tube Through Nasal Cavity (video-stylet)

Kaohsiung Medical University Chung-Ho Memorial Hospital

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

Study Overview

• Status: Completed
• Conditions: Nasotracheal Intubation
• Intervention / Treatment: Device: 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.

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Taiwan
  • Kaohsiung, Taiwan
    • Department of Anesthesiology, Kaohsiung Medical University Chung-Ho Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

patients undergoing regular oro-maxillofacial surgery are included in the study from a medical university hospital (medical center)

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
video-stylet tube assembly; patients who undergo oxo-maxillofacial surgery with nasotracheal intubation general anesthesia are recruited	Device: video-stylet; recording each video-stylet endotracheal tube assembly advanced through the selected nasal cavity

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
postoperative nasal damages	measurement of nasal bleeding and nasal congestion and nasal pain	24 hours

Collaborators and Investigators

• Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
• Investigators: Study Director: kuang I Cheng, MD, PhD, Kaohsiung Medical University Chung-Ho Memorial Hospital

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 5, 2017
• Primary Completion (Actual): August 8, 2019
• Study Completion (Actual): August 31, 2019

Study Registration Dates

• First Submitted: February 28, 2017
• First Submitted That Met QC Criteria: March 26, 2017
• First Posted (Actual): March 31, 2017

Study Record Updates

• Last Update Posted (Actual): June 21, 2024
• Last Update Submitted That Met QC Criteria: June 19, 2024
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: nasotracheal intubation; video-stylet; nasal cavity injury
• Other Study ID Numbers: KMUHIRB-E(II)_20160112

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No